Mixed Topics

Finding a fiber of good moral fiber

If you’ve ever wandered into the supplement aisle at your local grocery store, you’ve probably noticed an overabundance of fiber supplements that claim to do this for you and benefit that. Since there’s no Food and Drug Administration regulation on fiber supplements, manufacturers are free to (and do) make whatever wild claims they like. And much like choosing which of 500 shows to watch on Netflix, when you’re spoiled for choice, it can be difficult to pick.

Duke University Photo

Enter a team of molecular geneticists and microbiologists from Duke University. They can’t tell you what show to watch next, but they can tell you which fiber to choose, thanks to their new study. And the answer? Yes.

Well that’s not very helpful, but let us explain. For their study, a group of 28 received three of the main fiber supplements (inulin, dextrin, and galactooligosaccharides) for a week each, followed by a week off of fibers for their gut to return to baseline until they’d received all three. Those who consumed the least fiber at baseline saw the greatest benefit from fiber supplementation, with no appreciable difference between the three types. It was the same story for study participants who already consumed enough fiber; because their guts already hosted a more-optimal microbiome, the type of supplement didn’t matter. The benefits were the same across the board.

In an additional study, the Duke researchers found that gut microbiomes reacted to new fiber within a day, being primed to consume fiber on the first dose and digesting it more quickly on the second fiber dose.

The results, the researchers pointed out, make sense, since the average American only consumes 20%-40% of their daily recommended supply of fiber. Our digestive systems aren’t picky; they just want more, so go out there and choose whatever fiber you’d like. Do that, and then feel free to eat as many double bacon cheeseburgers as you’d like. That is the pinnacle of diet right there. Dietitians literally could not complain about it.
 

Jarlsberg vs. Camembert: This time it’s skeletal

Fiber is fabulous, of course, but the road to dietary health and wellness fulfillment takes us to many other, equally wondrous places. Hey, look! This next exit is covered with cheese.

PxHere

All the cheeses are here, from Abbaye de Belloc to Zwitser, and there, right between the jalapeno cheddar and the Jermi tortes you’ll find Jarlsberg, a mild, semisoft, nutty-flavored cheese that comes from Jarlsberg in eastern Norway. A recent study also suggests that Jarlsberg may help to prevent osteopenia and osteoporosis.

A group of Norwegian investigators gathered together 66 healthy women and gave them a daily portion of either Jarlsberg or Camembert for 6 weeks, at which point the Camembert group was switched to Jarlsberg for another 6 weeks.

The research team choose Camembert because of its similarity to Jarlsberg in fat and protein content. Jarlsberg, however, also is rich in vitamin K_{2, which is important for bone health,} and a substance known as DHNA, which “might combat bone thinning and increase bone tissue formation,” they said in a Eurekalert release.

After the first 6 weeks, blood levels of osteocalcin; vitamin K_{2; and} PINP, a peptide involved in bone turnover, were significantly higher in the Jarlsberg group only. All those measures rose significantly after the switch from Camembert to Jarlsberg, while levels of total and LDL cholesterol “fell significantly in the Camembert group after they switched to Jarlsberg,” the team added.

But wait! There’s more! HbA1c fell significantly among those initially eating the Jarlsberg but rose sharply in those eating Camembert. Do you see where this is going? After the Camembert group made the switch to Jarlsberg, their HbA1c levels fell significantly as well.

So it’s not just a cheese thing: The effects are specific to Jarlsberg. Can you guess what we’re having for lunch? Double bacon and fiber Jarlsbergers. Mmm, Jarlsburgers.
 

Luck be a lady: The mother of twins

It’s widely believed that women who have twins must be more fertile, giving birth to more than one child at a time. Some studies have supported the idea, but more recent work is refuting that claim. In actuality, it might just be more statistics and luck than fertility after all.

Michael Blackburn/istockphoto

Those earlier studies supporting fertility didn’t specify whether the chances of twin births were based on the ability to produce more than one egg at a time or on the number of births that women had overall. Looking at 100,000 preindustrial European births, before contraception was available, researchers from Norway, Germany, France, and the United Kingdom found that the number of total births, twins included, makes all the difference.

“When a woman gives birth several times, the chances increase that at least one of these births will be a twin birth,” investigator Gine Roll Skjærvø of the Norwegian University of Science and Technology said in a written statement.

Since twins occur in 1%-3% of all births, the more births that a woman has, the better her chances of giving birth to twins. The researchers compared it to playing the lottery. You buy enough tickets, eventually your numbers are going to come up. Despite that, however, they found that women who give birth to twins give birth less often than those who don’t have twins. Which raises the idea of sheer luck.

The researchers said that there’s still a lot to uncover in twin births, noting that “uncritically comparing groups of women with and without twins can trick us into believing the opposite of what is really true. These groupings may either hide the effects of twinning and fertility genes where they exist, or vice versa, create the illusion of these if they do not exist.”

For now, this new research claims that it’s basically a lottery. And women who give birth to twins hit the jackpot.
 

Those with low wages may be earning future memory loss

Not only are low wages detrimental to our souls, hopes, and dreams, but a new study shows that low wages also are linked to quicker memory decline later in life. Sustained low wages not only cause stress and food insecurity in the lives of many, but they also can cause diseases such as depression, obesity, and high blood pressure, which are risk factors for cognitive aging.

Nicola Barts/Pexels

The study was conducted using records from the Health and Retirement Study for the years 1992-2016 and focused on 2,879 adults born between 1936 and 1941. The participants were divided into three groups: those who never earned low wages, those who sometimes did, and those who always did.

The investigators found that workers who earned sustained low wages – defined as an hourly wage lower than two-thirds of the federal median wage for the corresponding year – “experienced significantly faster memory decline in older age” than did those who never earned low wages.

There are signs of inflation everywhere we look these days, but many people are not earning higher wages to compensate for the extra expenses. “Increasing the federal minimum wage, for example to $15 per hour, remains a gridlock issue in Congress,” lead author Katrina Kezios of the Columbia University Mailman School of Public Health, said in a statement released by the university.

If only salaries would rise instead of prices for once.

Finding a fiber of good moral fiber

If you’ve ever wandered into the supplement aisle at your local grocery store, you’ve probably noticed an overabundance of fiber supplements that claim to do this for you and benefit that. Since there’s no Food and Drug Administration regulation on fiber supplements, manufacturers are free to (and do) make whatever wild claims they like. And much like choosing which of 500 shows to watch on Netflix, when you’re spoiled for choice, it can be difficult to pick.

Duke University Photo

Enter a team of molecular geneticists and microbiologists from Duke University. They can’t tell you what show to watch next, but they can tell you which fiber to choose, thanks to their new study. And the answer? Yes.

Well that’s not very helpful, but let us explain. For their study, a group of 28 received three of the main fiber supplements (inulin, dextrin, and galactooligosaccharides) for a week each, followed by a week off of fibers for their gut to return to baseline until they’d received all three. Those who consumed the least fiber at baseline saw the greatest benefit from fiber supplementation, with no appreciable difference between the three types. It was the same story for study participants who already consumed enough fiber; because their guts already hosted a more-optimal microbiome, the type of supplement didn’t matter. The benefits were the same across the board.

In an additional study, the Duke researchers found that gut microbiomes reacted to new fiber within a day, being primed to consume fiber on the first dose and digesting it more quickly on the second fiber dose.

The results, the researchers pointed out, make sense, since the average American only consumes 20%-40% of their daily recommended supply of fiber. Our digestive systems aren’t picky; they just want more, so go out there and choose whatever fiber you’d like. Do that, and then feel free to eat as many double bacon cheeseburgers as you’d like. That is the pinnacle of diet right there. Dietitians literally could not complain about it.
 

Jarlsberg vs. Camembert: This time it’s skeletal

Fiber is fabulous, of course, but the road to dietary health and wellness fulfillment takes us to many other, equally wondrous places. Hey, look! This next exit is covered with cheese.

PxHere

All the cheeses are here, from Abbaye de Belloc to Zwitser, and there, right between the jalapeno cheddar and the Jermi tortes you’ll find Jarlsberg, a mild, semisoft, nutty-flavored cheese that comes from Jarlsberg in eastern Norway. A recent study also suggests that Jarlsberg may help to prevent osteopenia and osteoporosis.

A group of Norwegian investigators gathered together 66 healthy women and gave them a daily portion of either Jarlsberg or Camembert for 6 weeks, at which point the Camembert group was switched to Jarlsberg for another 6 weeks.

The research team choose Camembert because of its similarity to Jarlsberg in fat and protein content. Jarlsberg, however, also is rich in vitamin K_{2, which is important for bone health,} and a substance known as DHNA, which “might combat bone thinning and increase bone tissue formation,” they said in a Eurekalert release.

After the first 6 weeks, blood levels of osteocalcin; vitamin K_{2; and} PINP, a peptide involved in bone turnover, were significantly higher in the Jarlsberg group only. All those measures rose significantly after the switch from Camembert to Jarlsberg, while levels of total and LDL cholesterol “fell significantly in the Camembert group after they switched to Jarlsberg,” the team added.

But wait! There’s more! HbA1c fell significantly among those initially eating the Jarlsberg but rose sharply in those eating Camembert. Do you see where this is going? After the Camembert group made the switch to Jarlsberg, their HbA1c levels fell significantly as well.

So it’s not just a cheese thing: The effects are specific to Jarlsberg. Can you guess what we’re having for lunch? Double bacon and fiber Jarlsbergers. Mmm, Jarlsburgers.
 

Luck be a lady: The mother of twins

It’s widely believed that women who have twins must be more fertile, giving birth to more than one child at a time. Some studies have supported the idea, but more recent work is refuting that claim. In actuality, it might just be more statistics and luck than fertility after all.

Michael Blackburn/istockphoto

Those earlier studies supporting fertility didn’t specify whether the chances of twin births were based on the ability to produce more than one egg at a time or on the number of births that women had overall. Looking at 100,000 preindustrial European births, before contraception was available, researchers from Norway, Germany, France, and the United Kingdom found that the number of total births, twins included, makes all the difference.

“When a woman gives birth several times, the chances increase that at least one of these births will be a twin birth,” investigator Gine Roll Skjærvø of the Norwegian University of Science and Technology said in a written statement.

Since twins occur in 1%-3% of all births, the more births that a woman has, the better her chances of giving birth to twins. The researchers compared it to playing the lottery. You buy enough tickets, eventually your numbers are going to come up. Despite that, however, they found that women who give birth to twins give birth less often than those who don’t have twins. Which raises the idea of sheer luck.

The researchers said that there’s still a lot to uncover in twin births, noting that “uncritically comparing groups of women with and without twins can trick us into believing the opposite of what is really true. These groupings may either hide the effects of twinning and fertility genes where they exist, or vice versa, create the illusion of these if they do not exist.”

For now, this new research claims that it’s basically a lottery. And women who give birth to twins hit the jackpot.
 

Those with low wages may be earning future memory loss

Not only are low wages detrimental to our souls, hopes, and dreams, but a new study shows that low wages also are linked to quicker memory decline later in life. Sustained low wages not only cause stress and food insecurity in the lives of many, but they also can cause diseases such as depression, obesity, and high blood pressure, which are risk factors for cognitive aging.

Nicola Barts/Pexels

The study was conducted using records from the Health and Retirement Study for the years 1992-2016 and focused on 2,879 adults born between 1936 and 1941. The participants were divided into three groups: those who never earned low wages, those who sometimes did, and those who always did.

The investigators found that workers who earned sustained low wages – defined as an hourly wage lower than two-thirds of the federal median wage for the corresponding year – “experienced significantly faster memory decline in older age” than did those who never earned low wages.

There are signs of inflation everywhere we look these days, but many people are not earning higher wages to compensate for the extra expenses. “Increasing the federal minimum wage, for example to $15 per hour, remains a gridlock issue in Congress,” lead author Katrina Kezios of the Columbia University Mailman School of Public Health, said in a statement released by the university.

If only salaries would rise instead of prices for once.

Finding a fiber of good moral fiber

If you’ve ever wandered into the supplement aisle at your local grocery store, you’ve probably noticed an overabundance of fiber supplements that claim to do this for you and benefit that. Since there’s no Food and Drug Administration regulation on fiber supplements, manufacturers are free to (and do) make whatever wild claims they like. And much like choosing which of 500 shows to watch on Netflix, when you’re spoiled for choice, it can be difficult to pick.

Duke University Photo

Enter a team of molecular geneticists and microbiologists from Duke University. They can’t tell you what show to watch next, but they can tell you which fiber to choose, thanks to their new study. And the answer? Yes.

Well that’s not very helpful, but let us explain. For their study, a group of 28 received three of the main fiber supplements (inulin, dextrin, and galactooligosaccharides) for a week each, followed by a week off of fibers for their gut to return to baseline until they’d received all three. Those who consumed the least fiber at baseline saw the greatest benefit from fiber supplementation, with no appreciable difference between the three types. It was the same story for study participants who already consumed enough fiber; because their guts already hosted a more-optimal microbiome, the type of supplement didn’t matter. The benefits were the same across the board.

In an additional study, the Duke researchers found that gut microbiomes reacted to new fiber within a day, being primed to consume fiber on the first dose and digesting it more quickly on the second fiber dose.

The results, the researchers pointed out, make sense, since the average American only consumes 20%-40% of their daily recommended supply of fiber. Our digestive systems aren’t picky; they just want more, so go out there and choose whatever fiber you’d like. Do that, and then feel free to eat as many double bacon cheeseburgers as you’d like. That is the pinnacle of diet right there. Dietitians literally could not complain about it.
 

Jarlsberg vs. Camembert: This time it’s skeletal

Fiber is fabulous, of course, but the road to dietary health and wellness fulfillment takes us to many other, equally wondrous places. Hey, look! This next exit is covered with cheese.

PxHere

All the cheeses are here, from Abbaye de Belloc to Zwitser, and there, right between the jalapeno cheddar and the Jermi tortes you’ll find Jarlsberg, a mild, semisoft, nutty-flavored cheese that comes from Jarlsberg in eastern Norway. A recent study also suggests that Jarlsberg may help to prevent osteopenia and osteoporosis.

A group of Norwegian investigators gathered together 66 healthy women and gave them a daily portion of either Jarlsberg or Camembert for 6 weeks, at which point the Camembert group was switched to Jarlsberg for another 6 weeks.

The research team choose Camembert because of its similarity to Jarlsberg in fat and protein content. Jarlsberg, however, also is rich in vitamin K_{2, which is important for bone health,} and a substance known as DHNA, which “might combat bone thinning and increase bone tissue formation,” they said in a Eurekalert release.

After the first 6 weeks, blood levels of osteocalcin; vitamin K_{2; and} PINP, a peptide involved in bone turnover, were significantly higher in the Jarlsberg group only. All those measures rose significantly after the switch from Camembert to Jarlsberg, while levels of total and LDL cholesterol “fell significantly in the Camembert group after they switched to Jarlsberg,” the team added.

But wait! There’s more! HbA1c fell significantly among those initially eating the Jarlsberg but rose sharply in those eating Camembert. Do you see where this is going? After the Camembert group made the switch to Jarlsberg, their HbA1c levels fell significantly as well.

So it’s not just a cheese thing: The effects are specific to Jarlsberg. Can you guess what we’re having for lunch? Double bacon and fiber Jarlsbergers. Mmm, Jarlsburgers.
 

Luck be a lady: The mother of twins

It’s widely believed that women who have twins must be more fertile, giving birth to more than one child at a time. Some studies have supported the idea, but more recent work is refuting that claim. In actuality, it might just be more statistics and luck than fertility after all.

Michael Blackburn/istockphoto

Those earlier studies supporting fertility didn’t specify whether the chances of twin births were based on the ability to produce more than one egg at a time or on the number of births that women had overall. Looking at 100,000 preindustrial European births, before contraception was available, researchers from Norway, Germany, France, and the United Kingdom found that the number of total births, twins included, makes all the difference.

“When a woman gives birth several times, the chances increase that at least one of these births will be a twin birth,” investigator Gine Roll Skjærvø of the Norwegian University of Science and Technology said in a written statement.

Since twins occur in 1%-3% of all births, the more births that a woman has, the better her chances of giving birth to twins. The researchers compared it to playing the lottery. You buy enough tickets, eventually your numbers are going to come up. Despite that, however, they found that women who give birth to twins give birth less often than those who don’t have twins. Which raises the idea of sheer luck.

The researchers said that there’s still a lot to uncover in twin births, noting that “uncritically comparing groups of women with and without twins can trick us into believing the opposite of what is really true. These groupings may either hide the effects of twinning and fertility genes where they exist, or vice versa, create the illusion of these if they do not exist.”

For now, this new research claims that it’s basically a lottery. And women who give birth to twins hit the jackpot.
 

Those with low wages may be earning future memory loss

Not only are low wages detrimental to our souls, hopes, and dreams, but a new study shows that low wages also are linked to quicker memory decline later in life. Sustained low wages not only cause stress and food insecurity in the lives of many, but they also can cause diseases such as depression, obesity, and high blood pressure, which are risk factors for cognitive aging.

Nicola Barts/Pexels

The study was conducted using records from the Health and Retirement Study for the years 1992-2016 and focused on 2,879 adults born between 1936 and 1941. The participants were divided into three groups: those who never earned low wages, those who sometimes did, and those who always did.

The investigators found that workers who earned sustained low wages – defined as an hourly wage lower than two-thirds of the federal median wage for the corresponding year – “experienced significantly faster memory decline in older age” than did those who never earned low wages.

There are signs of inflation everywhere we look these days, but many people are not earning higher wages to compensate for the extra expenses. “Increasing the federal minimum wage, for example to $15 per hour, remains a gridlock issue in Congress,” lead author Katrina Kezios of the Columbia University Mailman School of Public Health, said in a statement released by the university.

If only salaries would rise instead of prices for once.

Huge win for patients: CRC screening coverage continuum is complete

In a huge win for patients, Medicare will begin covering colonoscopies after a positive noninvasive stool test starting next year. Medicare was previously the only insurer who did not cover this critical prevention procedure.

This change comes after a year of advocacy led by AGA – including multiple meetings with senior officials at Health & Human Services and legislative pressure by members across the country. 

“Cost-sharing is a well-recognized barrier to screening and has resulted in disparities.  Patients can now engage in CRC screening programs and be confident that they will not face unexpected cost-sharing for colonoscopy after a positive noninvasive screening test,” says David Lieberman, MD, AGAF, who met with Centers for Medicare & Medicaid Services officials multiple times to push this policy forward. “AGA knows that increased participation in screening will further reduce the burden of colorectal cancer.”

“This is a win for all patients and should elevate our nation’s screening rates while lowering the overall cancer burden, saving lives. Importantly, the CMS proposed rule changes will lessen colorectal cancer disparities eliminating a financial burden for many patients,” says AGA president John Carethers, MD, AGAF, who met with CMS earlier this month to advocate for this change.

Thank you to everyone in the GI community who advocated for this important change!

CMS announced the coverage change as part of the 2023 Medicare proposed rule, which was released July 7, 2022. The rule must be finalized this Fall before taking effect Jan. 2, 2023.
 

What you need to know about proposed changes to Medicare payment policies

On July 7, CMS released the calendar year (CY) 2023 Medicare Physician Fee Schedule (MPFS) Proposed Rule. The rule will be posted in the Federal Register no later than July 11.

Good news!
In a win for patients and thanks to collective advocacy efforts from AGA and partner societies, CMS is proposing to expand the regulatory definition of “colorectal cancer screening tests” and waive cost sharing for a necessary follow-up colonoscopy after a positive stool-based screening test.

Looming cuts 
The rule proposes 4% cuts to Medicare physician reimbursement through required decreases in the conversion factor and expiration of temporary fixes passed by Congress. AGA will continue to work with a coalition of national and state medical societies in urging Congress to prevent these cuts before Jan. 1, 2023.

What to know
CMS expands CRC screening in a proposal to waive cost-sharing for a follow-up colonoscopy to a positive stool-based colorectal cancer screening test and to cover the service for individuals 45 years of age and above.

Medicare payment cuts are looming with cuts to the proposed CY 2023 conversion factor.

Split/shared visits policy delayed until CY 2024.

Payment rates for new bariatric device codes proposed.
 

Don’t let insurance policies burden GI practices

Join us at AGA Advocacy Day on Thursday, Sept. 22, 2022, to virtually meet with your members of Congress to urge them to rein in insurance policies like prior authorization and step therapy. 

If GI providers don’t have a seat at the table and engage with lawmakers, these decisions will be influenced by payers and other parties that do not have you or your patients’ best interests at heart.  

AGA Advocacy Day is held shortly before the end of the fiscal year – prime time to educate policymakers and their staff about your everyday challenges and the reality of GI patient care in your state. We will also discuss the need for robust federal funding for GI research and the devastating impact that Medicare cuts could have on your practice. 

Register today and AGA will take care of the rest, including scheduling your meetings and providing comprehensive advocacy training. Now more than ever, your voice needs to be heard on Capitol Hill.

Huge win for patients: CRC screening coverage continuum is complete

In a huge win for patients, Medicare will begin covering colonoscopies after a positive noninvasive stool test starting next year. Medicare was previously the only insurer who did not cover this critical prevention procedure.

This change comes after a year of advocacy led by AGA – including multiple meetings with senior officials at Health & Human Services and legislative pressure by members across the country. 

“Cost-sharing is a well-recognized barrier to screening and has resulted in disparities.  Patients can now engage in CRC screening programs and be confident that they will not face unexpected cost-sharing for colonoscopy after a positive noninvasive screening test,” says David Lieberman, MD, AGAF, who met with Centers for Medicare & Medicaid Services officials multiple times to push this policy forward. “AGA knows that increased participation in screening will further reduce the burden of colorectal cancer.”

“This is a win for all patients and should elevate our nation’s screening rates while lowering the overall cancer burden, saving lives. Importantly, the CMS proposed rule changes will lessen colorectal cancer disparities eliminating a financial burden for many patients,” says AGA president John Carethers, MD, AGAF, who met with CMS earlier this month to advocate for this change.

Thank you to everyone in the GI community who advocated for this important change!

CMS announced the coverage change as part of the 2023 Medicare proposed rule, which was released July 7, 2022. The rule must be finalized this Fall before taking effect Jan. 2, 2023.
 

What you need to know about proposed changes to Medicare payment policies

On July 7, CMS released the calendar year (CY) 2023 Medicare Physician Fee Schedule (MPFS) Proposed Rule. The rule will be posted in the Federal Register no later than July 11.

Good news!
In a win for patients and thanks to collective advocacy efforts from AGA and partner societies, CMS is proposing to expand the regulatory definition of “colorectal cancer screening tests” and waive cost sharing for a necessary follow-up colonoscopy after a positive stool-based screening test.

Looming cuts 
The rule proposes 4% cuts to Medicare physician reimbursement through required decreases in the conversion factor and expiration of temporary fixes passed by Congress. AGA will continue to work with a coalition of national and state medical societies in urging Congress to prevent these cuts before Jan. 1, 2023.

What to know
CMS expands CRC screening in a proposal to waive cost-sharing for a follow-up colonoscopy to a positive stool-based colorectal cancer screening test and to cover the service for individuals 45 years of age and above.

Medicare payment cuts are looming with cuts to the proposed CY 2023 conversion factor.

Split/shared visits policy delayed until CY 2024.

Payment rates for new bariatric device codes proposed.
 

Don’t let insurance policies burden GI practices

Join us at AGA Advocacy Day on Thursday, Sept. 22, 2022, to virtually meet with your members of Congress to urge them to rein in insurance policies like prior authorization and step therapy. 

If GI providers don’t have a seat at the table and engage with lawmakers, these decisions will be influenced by payers and other parties that do not have you or your patients’ best interests at heart.  

AGA Advocacy Day is held shortly before the end of the fiscal year – prime time to educate policymakers and their staff about your everyday challenges and the reality of GI patient care in your state. We will also discuss the need for robust federal funding for GI research and the devastating impact that Medicare cuts could have on your practice. 

Register today and AGA will take care of the rest, including scheduling your meetings and providing comprehensive advocacy training. Now more than ever, your voice needs to be heard on Capitol Hill.

Huge win for patients: CRC screening coverage continuum is complete

In a huge win for patients, Medicare will begin covering colonoscopies after a positive noninvasive stool test starting next year. Medicare was previously the only insurer who did not cover this critical prevention procedure.

This change comes after a year of advocacy led by AGA – including multiple meetings with senior officials at Health & Human Services and legislative pressure by members across the country. 

“Cost-sharing is a well-recognized barrier to screening and has resulted in disparities.  Patients can now engage in CRC screening programs and be confident that they will not face unexpected cost-sharing for colonoscopy after a positive noninvasive screening test,” says David Lieberman, MD, AGAF, who met with Centers for Medicare & Medicaid Services officials multiple times to push this policy forward. “AGA knows that increased participation in screening will further reduce the burden of colorectal cancer.”

“This is a win for all patients and should elevate our nation’s screening rates while lowering the overall cancer burden, saving lives. Importantly, the CMS proposed rule changes will lessen colorectal cancer disparities eliminating a financial burden for many patients,” says AGA president John Carethers, MD, AGAF, who met with CMS earlier this month to advocate for this change.

Thank you to everyone in the GI community who advocated for this important change!

CMS announced the coverage change as part of the 2023 Medicare proposed rule, which was released July 7, 2022. The rule must be finalized this Fall before taking effect Jan. 2, 2023.
 

What you need to know about proposed changes to Medicare payment policies

On July 7, CMS released the calendar year (CY) 2023 Medicare Physician Fee Schedule (MPFS) Proposed Rule. The rule will be posted in the Federal Register no later than July 11.

Good news!
In a win for patients and thanks to collective advocacy efforts from AGA and partner societies, CMS is proposing to expand the regulatory definition of “colorectal cancer screening tests” and waive cost sharing for a necessary follow-up colonoscopy after a positive stool-based screening test.

Looming cuts 
The rule proposes 4% cuts to Medicare physician reimbursement through required decreases in the conversion factor and expiration of temporary fixes passed by Congress. AGA will continue to work with a coalition of national and state medical societies in urging Congress to prevent these cuts before Jan. 1, 2023.

What to know
CMS expands CRC screening in a proposal to waive cost-sharing for a follow-up colonoscopy to a positive stool-based colorectal cancer screening test and to cover the service for individuals 45 years of age and above.

Medicare payment cuts are looming with cuts to the proposed CY 2023 conversion factor.

Split/shared visits policy delayed until CY 2024.

Payment rates for new bariatric device codes proposed.
 

Don’t let insurance policies burden GI practices

Join us at AGA Advocacy Day on Thursday, Sept. 22, 2022, to virtually meet with your members of Congress to urge them to rein in insurance policies like prior authorization and step therapy. 

If GI providers don’t have a seat at the table and engage with lawmakers, these decisions will be influenced by payers and other parties that do not have you or your patients’ best interests at heart.  

AGA Advocacy Day is held shortly before the end of the fiscal year – prime time to educate policymakers and their staff about your everyday challenges and the reality of GI patient care in your state. We will also discuss the need for robust federal funding for GI research and the devastating impact that Medicare cuts could have on your practice. 

Register today and AGA will take care of the rest, including scheduling your meetings and providing comprehensive advocacy training. Now more than ever, your voice needs to be heard on Capitol Hill.

Some patients with blood cancers for whom all other therapeutic options have been exhausted have one final chance of getting rid of their disease: treatment with chimeric antigen-receptor (CAR) T cells.

Described as a “living drug,” the treatment involves genetically engineering the patient’s own blood cells and reinfusing them back into their system. These CAR T cells then hunt down and destroy cancer cells; in some cases, they manage to eradicate the disease completely.

About half of patients with leukemia or lymphoma and about a third of those with multiple myeloma who receive this treatment have a complete remission and achieve a functional “cure.”

But not all patients who could benefit from this therapy are able to get it. Some are spending months on waiting lists, often deteriorating while they wait. These patients have exhausted all other therapeutic options, and many are facing hospice and death.

The scope of this problem was illustrated by a recent survey of the centers that are certified to deliver this complex therapy.

The survey was led by Yi Lin, MD, PhD, associate professor of medicine at the Mayo Clinic, Rochester, Minn., and medical director for the cellular therapy program. It was published as an abstract at the annual meeting of the American Society of Clinical Oncology recently, although it was not presented there.

“We wanted to find out just how widespread this problem is,” Dr. Lin said, adding: “There had been nothing in the literature thus far about it.”

The team contacted 20 centers across the United States and received responses from 17. Results showed that the median time on the waiting list was 6 months and that only 25% of patients eventually received CAR T-cell therapy. An additional 25% were able to enter a CAR T clinical trial. The remaining 50% of patients either were enrolled in a different type of trial, entered hospice, or died.

For patient selection, all centers reported using a committee of experienced physicians to ensure consistency. They employed different ethical principles for selection. Some centers sought to maximize the total benefit, such as selecting the patients most likely to achieve leukapheresis or a clinical response, while others based their decisions on the time patients spent on waiting list or gave priority to the patients who were the “worst off” with the most limited therapeutic options.
 

Shortage affecting mostly myeloma patients

The shortages in CAR T-cell therapies primarily involve the products used for patients with multiple myeloma.

The problem has not, as yet, noticeably spilled over to lymphoma and leukemia treatments, which use a slightly different type of CAR T-cell therapy (it targets CD19, whereas the cell therapies used for myeloma target BCMA).

“We have backlog of myeloma patients who don’t have access,” said Nina Shah, MD, a hematologist and professor of medicine at the University of California, San Francisco. “We have only four slots for the two myeloma products but about 50-60 eligible patients.”

Long waiting times for CAR T cells for myeloma have been an issue ever since the first of these products appeared on the market: idecabtagene vicleucel (ide-cel; Abecma), developed by Bluebird Bio and Bristol-Myers Squibb. “As soon as it became available in March 2021, we had people waiting and limits on our access to it,” Dr. Shah said.

A second CAR T-cell therapy for myeloma, ciltacabtagene autoleucel (cilta-cel, Carvykti), developed by Janssen and Legend Biotech, received approval in February 2022. While that helped provide centers with a few more slots, it wasn’t sufficient to cut waiting times, and the demand for these myeloma therapies continues to outstrip the capacity to produce CAR-T products in a timely manner.

“For myeloma, the demand is very high, as most patients are not cured from any other existing myeloma therapies, and most patients will make it to fifth-line therapy where the two CAR T-cell products are approved right now,” said Krina K. Patel, MD, medical director of the department of lymphoma/myeloma in the division of cancer medicine at the University of Texas MD Anderson Cancer Center, Houston.

“We likely have 10 eligible CAR-T myeloma patients each month at our center,” she said, “but were getting two slots per month for the past 8 months, and now are getting four slots a month.”

“Our clinic has also experienced the impact of the low number of manufacturing slots offered to each cancer center for some CAR T-cell products,” said David Maloney, MD, PhD, medical director, Cellular Immunotherapy and Bezos Family Immunotherapy Clinic, Seattle Cancer Care Alliance.

He noted that, as with other cancer centers, for multiple myeloma they are provided a specific number of manufacturing slots for each treatment. “Our providers discuss which patients are most appropriate for available slots for that month,” said Dr. Maloney.

“Additionally, juggling patient schedules may be required to address the extended manufacturing time for some products. In some cases, clinical trials may be available in a more timely fashion for appropriate patients, and in some cases, switching to an alternative product is possible,” he commented.
 

Complex causes behind bottleneck

The cause of the current bottleneck for myeloma patients is complex. It stems from a shortage of raw materials and supply chain restraints, among other things.

While the biggest impact of shortages has been on patients with multiple myeloma, Dr. Patel pointed out that these constraints are also affecting patients with lymphoma at her institution, but to a lesser degree.

“This is multifactorial as to why, but most of the issues arise from manufacturing,” Dr. Patel said in an interview. “Initially, the FDA limited how many slots each new product could have per month, then there was a viral vector shortage, and then the quality-control process the FDA requires takes longer than the manufacturing of the cells actually do.”

On top of that, “we have about a 5% manufacturing fail rate so far,” she added. Such failures occur when the cells taken from a patient cannot be converted into CAR T cells for therapy.

Matthew J. Frigault, MD, from the Center for Cellular Therapies, Mass General Cancer Center, Boston, explained that the growing excitement about the potential for cellular therapy and recent approvals for these products for use in earlier lines of treatment have increased demand for them.

There are also problems regarding supply. Manufacture and delivery of CAR T is complicated and takes time to scale up, Dr. Frigault pointed out. “Therefore, we are seeing limited access, more so for the BCMA-directed therapies [which are used for myeloma].”

The shortages and delays likely involve two main factors. “For the newer indications, there is a significant backlog of patients who have been waiting for these therapies and have not been able to access them in the clinical trial setting, and manufacturing is extremely complicated and not easily scaled up,” he said.

“That being said, manufacturers are trying to increase the number of available manufacturing slots and decrease the time needed to manufacture cells,” Dr. Frigault commented.

Delays in access to myeloma CAR T-cell therapy are also affecting patient care at Fox Chase Cancer Center in Philadelphia. “We have had about one slot every 2 months for Abecma,” noted Henry Fung, MD, chair of the department of bone marrow transplant and cellular therapies at Fox Chase. “For Carvykti, there are only 32 certified centers in [the] U.S., and access is very limited.”

Dr. Fung explained that they have had to offer alternative treatments to many of their patients. “There are rumors that there’s shortage in obtaining raw materials, such as the virus used for transduction, although we have not encountered any problems in other CAR T products used for lymphomas.”
 

Pharma companies trying to meet the demand

This news organization reached out to the manufacturers of CAR T products. All have reported that they are doing what they feasibly can to ramp up production.

“The complexity of delivering CAR T-cell therapies is unlike any other traditional biologic or small-molecule medicine, using a patient’s own cells to start a highly sophisticated and personalized manufacturing process,” commented a spokesperson for BMS, which has two CAR T-cell products currently on the market.

“In this nascent field of cell therapy, we continue to evolve every day, addressing supply and manufacturing challenges head on by applying key learnings across our three state-of-the-art cell therapy facilities and two new facilities in progress.

“We have been encouraged by a steady increase in our manufacturing capacity, and we continue efforts to ramp up further to meet the demand for our cell therapies,” the BMS spokesperson commented. “We have already seen improvements in the stabilization of vector supply and expect additional improvements in capacity in the second half of 2022.”

Novartis said much the same thing. They have a “comprehensive, integrated global CAR-T manufacturing footprint that strengthens the flexibility, resilience, and sustainability of the Novartis manufacturing and supply chain. Together with an improved manufacturing process, we are confident in our ability to meet patient demand with timely delivery,” according to a Novartis spokesperson.

The spokesperson also pointed out that the company has continuously incorporated process improvements that have significantly increased manufacturing capacity and success rates for patients in need of CAR T cells.

“Data presented at [the] American Society of Hematology annual meeting in 2021 showed the Novartis Morris Plains facility, our flagship CAR T manufacturing site, had commercial manufacturing and shipping success rates of 96% and 99%, respectively, between January and August 2021,” according to the spokesperson.

Legend and Janssen, the companies behind Carvykti, one of the two approved cell products for myeloma, which launched earlier in 2022, said that they have continued to activate certified treatment centers in a phased approach that will enable them to expand availability throughout 2022 and beyond.

“This phased approach was designed to ensure the highest level of predictability and reliability for the patient and the certified treatment centers,” the spokesperson said. “We understand the urgency for patients in need of Carvyki and are committed to doing everything we can to accelerate our ability to deliver this important cell therapy in a reliable and timely manner.”

With regard to the industry-wide supply shortage of lentivirus, Legend and Janssen say they have put in place multiple processes to address the shortage, “including enhancing our own internal manufacturing capabilities of this essential drug substance, to ensure sufficient and sustained supply.”
 

Incredibly exciting potential

Given the immense potential of CAR T-cell therapy, the supply shortage that myeloma patients are experiencing is all the more poignant and distressing. While not everyone benefits, some patients for whom every other therapy failed and who were facing hospice have had dramatic results.

“Incredibly exciting with unbelievable potential” was how one expert described these new therapies when the first product was about to enter the marketplace. Since then, six CAR T-cell therapies have received regulatory approval for an ever-increasing range of hematologic malignancies.

But these CAR T-cell therapies have their own set of adverse events, which can be serious and even life-threatening. In addition, not all patients become cancer free, although long-term data are impressive.

A study that included one of the longest follow-ups to date was reported at the 2020 annual meeting of the American Society of Clinical Oncology. The researchers reported that remissions lasted over 9 years for patients with relapsed/refractory B-cell lymphoma or chronic lymphocytic leukemia who underwent treatment with Kite’s axicaptagene cilleucel (Yescarta). This review included 43 patients and showed an overall remission rate of 76%. Complete remission was achieved for 54% of patients, and partial remission was achieved for 22%.

The results with CAR T-cell therapy in multiple myeloma are not quite as impressive, but even so, the clinical data that supported the approval of Abecma showed that a third of patients, who had previously received a median of six prior therapies, achieved a complete response.

At the time of the Abecma approval, the lead investigator of the study, Nikhil Munshi, MD, of Dana-Farber Cancer Institute, Boston, commented: “The results of this trial represent a true turning point in the treatment of this disease. In my 30 years of treating myeloma, I have not seen any other therapy as effective in this group of patients.”

A version of this article first appeared on Medscape.com.

Some patients with blood cancers for whom all other therapeutic options have been exhausted have one final chance of getting rid of their disease: treatment with chimeric antigen-receptor (CAR) T cells.

Described as a “living drug,” the treatment involves genetically engineering the patient’s own blood cells and reinfusing them back into their system. These CAR T cells then hunt down and destroy cancer cells; in some cases, they manage to eradicate the disease completely.

About half of patients with leukemia or lymphoma and about a third of those with multiple myeloma who receive this treatment have a complete remission and achieve a functional “cure.”

But not all patients who could benefit from this therapy are able to get it. Some are spending months on waiting lists, often deteriorating while they wait. These patients have exhausted all other therapeutic options, and many are facing hospice and death.

The scope of this problem was illustrated by a recent survey of the centers that are certified to deliver this complex therapy.

The survey was led by Yi Lin, MD, PhD, associate professor of medicine at the Mayo Clinic, Rochester, Minn., and medical director for the cellular therapy program. It was published as an abstract at the annual meeting of the American Society of Clinical Oncology recently, although it was not presented there.

“We wanted to find out just how widespread this problem is,” Dr. Lin said, adding: “There had been nothing in the literature thus far about it.”

The team contacted 20 centers across the United States and received responses from 17. Results showed that the median time on the waiting list was 6 months and that only 25% of patients eventually received CAR T-cell therapy. An additional 25% were able to enter a CAR T clinical trial. The remaining 50% of patients either were enrolled in a different type of trial, entered hospice, or died.

For patient selection, all centers reported using a committee of experienced physicians to ensure consistency. They employed different ethical principles for selection. Some centers sought to maximize the total benefit, such as selecting the patients most likely to achieve leukapheresis or a clinical response, while others based their decisions on the time patients spent on waiting list or gave priority to the patients who were the “worst off” with the most limited therapeutic options.
 

Shortage affecting mostly myeloma patients

The shortages in CAR T-cell therapies primarily involve the products used for patients with multiple myeloma.

The problem has not, as yet, noticeably spilled over to lymphoma and leukemia treatments, which use a slightly different type of CAR T-cell therapy (it targets CD19, whereas the cell therapies used for myeloma target BCMA).

“We have backlog of myeloma patients who don’t have access,” said Nina Shah, MD, a hematologist and professor of medicine at the University of California, San Francisco. “We have only four slots for the two myeloma products but about 50-60 eligible patients.”

Long waiting times for CAR T cells for myeloma have been an issue ever since the first of these products appeared on the market: idecabtagene vicleucel (ide-cel; Abecma), developed by Bluebird Bio and Bristol-Myers Squibb. “As soon as it became available in March 2021, we had people waiting and limits on our access to it,” Dr. Shah said.

A second CAR T-cell therapy for myeloma, ciltacabtagene autoleucel (cilta-cel, Carvykti), developed by Janssen and Legend Biotech, received approval in February 2022. While that helped provide centers with a few more slots, it wasn’t sufficient to cut waiting times, and the demand for these myeloma therapies continues to outstrip the capacity to produce CAR-T products in a timely manner.

“For myeloma, the demand is very high, as most patients are not cured from any other existing myeloma therapies, and most patients will make it to fifth-line therapy where the two CAR T-cell products are approved right now,” said Krina K. Patel, MD, medical director of the department of lymphoma/myeloma in the division of cancer medicine at the University of Texas MD Anderson Cancer Center, Houston.

“We likely have 10 eligible CAR-T myeloma patients each month at our center,” she said, “but were getting two slots per month for the past 8 months, and now are getting four slots a month.”

“Our clinic has also experienced the impact of the low number of manufacturing slots offered to each cancer center for some CAR T-cell products,” said David Maloney, MD, PhD, medical director, Cellular Immunotherapy and Bezos Family Immunotherapy Clinic, Seattle Cancer Care Alliance.

He noted that, as with other cancer centers, for multiple myeloma they are provided a specific number of manufacturing slots for each treatment. “Our providers discuss which patients are most appropriate for available slots for that month,” said Dr. Maloney.

“Additionally, juggling patient schedules may be required to address the extended manufacturing time for some products. In some cases, clinical trials may be available in a more timely fashion for appropriate patients, and in some cases, switching to an alternative product is possible,” he commented.
 

Complex causes behind bottleneck

The cause of the current bottleneck for myeloma patients is complex. It stems from a shortage of raw materials and supply chain restraints, among other things.

While the biggest impact of shortages has been on patients with multiple myeloma, Dr. Patel pointed out that these constraints are also affecting patients with lymphoma at her institution, but to a lesser degree.

“This is multifactorial as to why, but most of the issues arise from manufacturing,” Dr. Patel said in an interview. “Initially, the FDA limited how many slots each new product could have per month, then there was a viral vector shortage, and then the quality-control process the FDA requires takes longer than the manufacturing of the cells actually do.”

On top of that, “we have about a 5% manufacturing fail rate so far,” she added. Such failures occur when the cells taken from a patient cannot be converted into CAR T cells for therapy.

Matthew J. Frigault, MD, from the Center for Cellular Therapies, Mass General Cancer Center, Boston, explained that the growing excitement about the potential for cellular therapy and recent approvals for these products for use in earlier lines of treatment have increased demand for them.

There are also problems regarding supply. Manufacture and delivery of CAR T is complicated and takes time to scale up, Dr. Frigault pointed out. “Therefore, we are seeing limited access, more so for the BCMA-directed therapies [which are used for myeloma].”

The shortages and delays likely involve two main factors. “For the newer indications, there is a significant backlog of patients who have been waiting for these therapies and have not been able to access them in the clinical trial setting, and manufacturing is extremely complicated and not easily scaled up,” he said.

“That being said, manufacturers are trying to increase the number of available manufacturing slots and decrease the time needed to manufacture cells,” Dr. Frigault commented.

Delays in access to myeloma CAR T-cell therapy are also affecting patient care at Fox Chase Cancer Center in Philadelphia. “We have had about one slot every 2 months for Abecma,” noted Henry Fung, MD, chair of the department of bone marrow transplant and cellular therapies at Fox Chase. “For Carvykti, there are only 32 certified centers in [the] U.S., and access is very limited.”

Dr. Fung explained that they have had to offer alternative treatments to many of their patients. “There are rumors that there’s shortage in obtaining raw materials, such as the virus used for transduction, although we have not encountered any problems in other CAR T products used for lymphomas.”
 

Pharma companies trying to meet the demand

This news organization reached out to the manufacturers of CAR T products. All have reported that they are doing what they feasibly can to ramp up production.

“The complexity of delivering CAR T-cell therapies is unlike any other traditional biologic or small-molecule medicine, using a patient’s own cells to start a highly sophisticated and personalized manufacturing process,” commented a spokesperson for BMS, which has two CAR T-cell products currently on the market.

“In this nascent field of cell therapy, we continue to evolve every day, addressing supply and manufacturing challenges head on by applying key learnings across our three state-of-the-art cell therapy facilities and two new facilities in progress.

“We have been encouraged by a steady increase in our manufacturing capacity, and we continue efforts to ramp up further to meet the demand for our cell therapies,” the BMS spokesperson commented. “We have already seen improvements in the stabilization of vector supply and expect additional improvements in capacity in the second half of 2022.”

Novartis said much the same thing. They have a “comprehensive, integrated global CAR-T manufacturing footprint that strengthens the flexibility, resilience, and sustainability of the Novartis manufacturing and supply chain. Together with an improved manufacturing process, we are confident in our ability to meet patient demand with timely delivery,” according to a Novartis spokesperson.

The spokesperson also pointed out that the company has continuously incorporated process improvements that have significantly increased manufacturing capacity and success rates for patients in need of CAR T cells.

“Data presented at [the] American Society of Hematology annual meeting in 2021 showed the Novartis Morris Plains facility, our flagship CAR T manufacturing site, had commercial manufacturing and shipping success rates of 96% and 99%, respectively, between January and August 2021,” according to the spokesperson.

Legend and Janssen, the companies behind Carvykti, one of the two approved cell products for myeloma, which launched earlier in 2022, said that they have continued to activate certified treatment centers in a phased approach that will enable them to expand availability throughout 2022 and beyond.

“This phased approach was designed to ensure the highest level of predictability and reliability for the patient and the certified treatment centers,” the spokesperson said. “We understand the urgency for patients in need of Carvyki and are committed to doing everything we can to accelerate our ability to deliver this important cell therapy in a reliable and timely manner.”

With regard to the industry-wide supply shortage of lentivirus, Legend and Janssen say they have put in place multiple processes to address the shortage, “including enhancing our own internal manufacturing capabilities of this essential drug substance, to ensure sufficient and sustained supply.”
 

Incredibly exciting potential

Given the immense potential of CAR T-cell therapy, the supply shortage that myeloma patients are experiencing is all the more poignant and distressing. While not everyone benefits, some patients for whom every other therapy failed and who were facing hospice have had dramatic results.

“Incredibly exciting with unbelievable potential” was how one expert described these new therapies when the first product was about to enter the marketplace. Since then, six CAR T-cell therapies have received regulatory approval for an ever-increasing range of hematologic malignancies.

But these CAR T-cell therapies have their own set of adverse events, which can be serious and even life-threatening. In addition, not all patients become cancer free, although long-term data are impressive.

A study that included one of the longest follow-ups to date was reported at the 2020 annual meeting of the American Society of Clinical Oncology. The researchers reported that remissions lasted over 9 years for patients with relapsed/refractory B-cell lymphoma or chronic lymphocytic leukemia who underwent treatment with Kite’s axicaptagene cilleucel (Yescarta). This review included 43 patients and showed an overall remission rate of 76%. Complete remission was achieved for 54% of patients, and partial remission was achieved for 22%.

The results with CAR T-cell therapy in multiple myeloma are not quite as impressive, but even so, the clinical data that supported the approval of Abecma showed that a third of patients, who had previously received a median of six prior therapies, achieved a complete response.

At the time of the Abecma approval, the lead investigator of the study, Nikhil Munshi, MD, of Dana-Farber Cancer Institute, Boston, commented: “The results of this trial represent a true turning point in the treatment of this disease. In my 30 years of treating myeloma, I have not seen any other therapy as effective in this group of patients.”

A version of this article first appeared on Medscape.com.

Some patients with blood cancers for whom all other therapeutic options have been exhausted have one final chance of getting rid of their disease: treatment with chimeric antigen-receptor (CAR) T cells.

Described as a “living drug,” the treatment involves genetically engineering the patient’s own blood cells and reinfusing them back into their system. These CAR T cells then hunt down and destroy cancer cells; in some cases, they manage to eradicate the disease completely.

About half of patients with leukemia or lymphoma and about a third of those with multiple myeloma who receive this treatment have a complete remission and achieve a functional “cure.”

But not all patients who could benefit from this therapy are able to get it. Some are spending months on waiting lists, often deteriorating while they wait. These patients have exhausted all other therapeutic options, and many are facing hospice and death.

The scope of this problem was illustrated by a recent survey of the centers that are certified to deliver this complex therapy.

The survey was led by Yi Lin, MD, PhD, associate professor of medicine at the Mayo Clinic, Rochester, Minn., and medical director for the cellular therapy program. It was published as an abstract at the annual meeting of the American Society of Clinical Oncology recently, although it was not presented there.

“We wanted to find out just how widespread this problem is,” Dr. Lin said, adding: “There had been nothing in the literature thus far about it.”

The team contacted 20 centers across the United States and received responses from 17. Results showed that the median time on the waiting list was 6 months and that only 25% of patients eventually received CAR T-cell therapy. An additional 25% were able to enter a CAR T clinical trial. The remaining 50% of patients either were enrolled in a different type of trial, entered hospice, or died.

For patient selection, all centers reported using a committee of experienced physicians to ensure consistency. They employed different ethical principles for selection. Some centers sought to maximize the total benefit, such as selecting the patients most likely to achieve leukapheresis or a clinical response, while others based their decisions on the time patients spent on waiting list or gave priority to the patients who were the “worst off” with the most limited therapeutic options.
 

Shortage affecting mostly myeloma patients

The shortages in CAR T-cell therapies primarily involve the products used for patients with multiple myeloma.

The problem has not, as yet, noticeably spilled over to lymphoma and leukemia treatments, which use a slightly different type of CAR T-cell therapy (it targets CD19, whereas the cell therapies used for myeloma target BCMA).

“We have backlog of myeloma patients who don’t have access,” said Nina Shah, MD, a hematologist and professor of medicine at the University of California, San Francisco. “We have only four slots for the two myeloma products but about 50-60 eligible patients.”

Long waiting times for CAR T cells for myeloma have been an issue ever since the first of these products appeared on the market: idecabtagene vicleucel (ide-cel; Abecma), developed by Bluebird Bio and Bristol-Myers Squibb. “As soon as it became available in March 2021, we had people waiting and limits on our access to it,” Dr. Shah said.

A second CAR T-cell therapy for myeloma, ciltacabtagene autoleucel (cilta-cel, Carvykti), developed by Janssen and Legend Biotech, received approval in February 2022. While that helped provide centers with a few more slots, it wasn’t sufficient to cut waiting times, and the demand for these myeloma therapies continues to outstrip the capacity to produce CAR-T products in a timely manner.

“For myeloma, the demand is very high, as most patients are not cured from any other existing myeloma therapies, and most patients will make it to fifth-line therapy where the two CAR T-cell products are approved right now,” said Krina K. Patel, MD, medical director of the department of lymphoma/myeloma in the division of cancer medicine at the University of Texas MD Anderson Cancer Center, Houston.

“We likely have 10 eligible CAR-T myeloma patients each month at our center,” she said, “but were getting two slots per month for the past 8 months, and now are getting four slots a month.”

“Our clinic has also experienced the impact of the low number of manufacturing slots offered to each cancer center for some CAR T-cell products,” said David Maloney, MD, PhD, medical director, Cellular Immunotherapy and Bezos Family Immunotherapy Clinic, Seattle Cancer Care Alliance.

He noted that, as with other cancer centers, for multiple myeloma they are provided a specific number of manufacturing slots for each treatment. “Our providers discuss which patients are most appropriate for available slots for that month,” said Dr. Maloney.

“Additionally, juggling patient schedules may be required to address the extended manufacturing time for some products. In some cases, clinical trials may be available in a more timely fashion for appropriate patients, and in some cases, switching to an alternative product is possible,” he commented.
 

Complex causes behind bottleneck

The cause of the current bottleneck for myeloma patients is complex. It stems from a shortage of raw materials and supply chain restraints, among other things.

While the biggest impact of shortages has been on patients with multiple myeloma, Dr. Patel pointed out that these constraints are also affecting patients with lymphoma at her institution, but to a lesser degree.

“This is multifactorial as to why, but most of the issues arise from manufacturing,” Dr. Patel said in an interview. “Initially, the FDA limited how many slots each new product could have per month, then there was a viral vector shortage, and then the quality-control process the FDA requires takes longer than the manufacturing of the cells actually do.”

On top of that, “we have about a 5% manufacturing fail rate so far,” she added. Such failures occur when the cells taken from a patient cannot be converted into CAR T cells for therapy.

Matthew J. Frigault, MD, from the Center for Cellular Therapies, Mass General Cancer Center, Boston, explained that the growing excitement about the potential for cellular therapy and recent approvals for these products for use in earlier lines of treatment have increased demand for them.

There are also problems regarding supply. Manufacture and delivery of CAR T is complicated and takes time to scale up, Dr. Frigault pointed out. “Therefore, we are seeing limited access, more so for the BCMA-directed therapies [which are used for myeloma].”

The shortages and delays likely involve two main factors. “For the newer indications, there is a significant backlog of patients who have been waiting for these therapies and have not been able to access them in the clinical trial setting, and manufacturing is extremely complicated and not easily scaled up,” he said.

“That being said, manufacturers are trying to increase the number of available manufacturing slots and decrease the time needed to manufacture cells,” Dr. Frigault commented.

Delays in access to myeloma CAR T-cell therapy are also affecting patient care at Fox Chase Cancer Center in Philadelphia. “We have had about one slot every 2 months for Abecma,” noted Henry Fung, MD, chair of the department of bone marrow transplant and cellular therapies at Fox Chase. “For Carvykti, there are only 32 certified centers in [the] U.S., and access is very limited.”

Dr. Fung explained that they have had to offer alternative treatments to many of their patients. “There are rumors that there’s shortage in obtaining raw materials, such as the virus used for transduction, although we have not encountered any problems in other CAR T products used for lymphomas.”
 

Pharma companies trying to meet the demand

This news organization reached out to the manufacturers of CAR T products. All have reported that they are doing what they feasibly can to ramp up production.

“The complexity of delivering CAR T-cell therapies is unlike any other traditional biologic or small-molecule medicine, using a patient’s own cells to start a highly sophisticated and personalized manufacturing process,” commented a spokesperson for BMS, which has two CAR T-cell products currently on the market.

“In this nascent field of cell therapy, we continue to evolve every day, addressing supply and manufacturing challenges head on by applying key learnings across our three state-of-the-art cell therapy facilities and two new facilities in progress.

“We have been encouraged by a steady increase in our manufacturing capacity, and we continue efforts to ramp up further to meet the demand for our cell therapies,” the BMS spokesperson commented. “We have already seen improvements in the stabilization of vector supply and expect additional improvements in capacity in the second half of 2022.”

Novartis said much the same thing. They have a “comprehensive, integrated global CAR-T manufacturing footprint that strengthens the flexibility, resilience, and sustainability of the Novartis manufacturing and supply chain. Together with an improved manufacturing process, we are confident in our ability to meet patient demand with timely delivery,” according to a Novartis spokesperson.

The spokesperson also pointed out that the company has continuously incorporated process improvements that have significantly increased manufacturing capacity and success rates for patients in need of CAR T cells.

“Data presented at [the] American Society of Hematology annual meeting in 2021 showed the Novartis Morris Plains facility, our flagship CAR T manufacturing site, had commercial manufacturing and shipping success rates of 96% and 99%, respectively, between January and August 2021,” according to the spokesperson.

Legend and Janssen, the companies behind Carvykti, one of the two approved cell products for myeloma, which launched earlier in 2022, said that they have continued to activate certified treatment centers in a phased approach that will enable them to expand availability throughout 2022 and beyond.

“This phased approach was designed to ensure the highest level of predictability and reliability for the patient and the certified treatment centers,” the spokesperson said. “We understand the urgency for patients in need of Carvyki and are committed to doing everything we can to accelerate our ability to deliver this important cell therapy in a reliable and timely manner.”

With regard to the industry-wide supply shortage of lentivirus, Legend and Janssen say they have put in place multiple processes to address the shortage, “including enhancing our own internal manufacturing capabilities of this essential drug substance, to ensure sufficient and sustained supply.”
 

Incredibly exciting potential

Given the immense potential of CAR T-cell therapy, the supply shortage that myeloma patients are experiencing is all the more poignant and distressing. While not everyone benefits, some patients for whom every other therapy failed and who were facing hospice have had dramatic results.

“Incredibly exciting with unbelievable potential” was how one expert described these new therapies when the first product was about to enter the marketplace. Since then, six CAR T-cell therapies have received regulatory approval for an ever-increasing range of hematologic malignancies.

But these CAR T-cell therapies have their own set of adverse events, which can be serious and even life-threatening. In addition, not all patients become cancer free, although long-term data are impressive.

A study that included one of the longest follow-ups to date was reported at the 2020 annual meeting of the American Society of Clinical Oncology. The researchers reported that remissions lasted over 9 years for patients with relapsed/refractory B-cell lymphoma or chronic lymphocytic leukemia who underwent treatment with Kite’s axicaptagene cilleucel (Yescarta). This review included 43 patients and showed an overall remission rate of 76%. Complete remission was achieved for 54% of patients, and partial remission was achieved for 22%.

The results with CAR T-cell therapy in multiple myeloma are not quite as impressive, but even so, the clinical data that supported the approval of Abecma showed that a third of patients, who had previously received a median of six prior therapies, achieved a complete response.

At the time of the Abecma approval, the lead investigator of the study, Nikhil Munshi, MD, of Dana-Farber Cancer Institute, Boston, commented: “The results of this trial represent a true turning point in the treatment of this disease. In my 30 years of treating myeloma, I have not seen any other therapy as effective in this group of patients.”

A version of this article first appeared on Medscape.com.

After the US Supreme Court overturned Roe v Wade in June, Gilbert R. Cisneros Jr., Under Secretary of Defense for Personnel and Readiness, released a memo on “Ensuring Access to Essential Women’s Health Care Services for Service Members, Dependents, Beneficiaries, and Department of Defense Civilian Employees.” In the memo, Cisneros clarified the US Department of Defense (DoD) policies and emphasized, “There will be no interruption to this care.”

Covered abortions—instances where the life of the mother would be endangered if the fetus were carried to term, or when the pregnancy is the result of rape or incest—are still covered. Health care professionals will continue to follow this policy and military medical facilities leadership will implement measures to ensure continued access to care.

The implications of the Supreme Court decision are complicated, Cisneros said. “It is the Department of Justice’s longstanding position that States generally may not impose criminal or civil liability on federal employees who perform their duties in a manner authorized by federal law,” the memo continues. “We will work with the Department of Justice to ensure access to counsel for such civilian employees and Service members if needed and as appropriate.”

The decision also does not affect the DoD’s existing leave policies, which authorize active-duty service members to travel as necessary to receive abortion care. The travel may be government-funded official travel for a covered abortion, or for all other cases, may be undertaken as regular leave at the service member’s expense. DoD civilian employees may continue to use sick leave or other forms of leave to care for themselves or their family members. Sick leave may be used to cover travel to obtain any type of medical treatment.

The Court’s decision “will have significant implications,” Cisneros wrote, adding, “As Secretary Austin has made clear, nothing is more important than the health and well-being of our Service members, the civilian workforce, and DoD families, and we are committed to taking care of all our people and ensuring that the entire Force remains ready and resilient.”

After the US Supreme Court overturned Roe v Wade in June, Gilbert R. Cisneros Jr., Under Secretary of Defense for Personnel and Readiness, released a memo on “Ensuring Access to Essential Women’s Health Care Services for Service Members, Dependents, Beneficiaries, and Department of Defense Civilian Employees.” In the memo, Cisneros clarified the US Department of Defense (DoD) policies and emphasized, “There will be no interruption to this care.”

Covered abortions—instances where the life of the mother would be endangered if the fetus were carried to term, or when the pregnancy is the result of rape or incest—are still covered. Health care professionals will continue to follow this policy and military medical facilities leadership will implement measures to ensure continued access to care.

The implications of the Supreme Court decision are complicated, Cisneros said. “It is the Department of Justice’s longstanding position that States generally may not impose criminal or civil liability on federal employees who perform their duties in a manner authorized by federal law,” the memo continues. “We will work with the Department of Justice to ensure access to counsel for such civilian employees and Service members if needed and as appropriate.”

The decision also does not affect the DoD’s existing leave policies, which authorize active-duty service members to travel as necessary to receive abortion care. The travel may be government-funded official travel for a covered abortion, or for all other cases, may be undertaken as regular leave at the service member’s expense. DoD civilian employees may continue to use sick leave or other forms of leave to care for themselves or their family members. Sick leave may be used to cover travel to obtain any type of medical treatment.

The Court’s decision “will have significant implications,” Cisneros wrote, adding, “As Secretary Austin has made clear, nothing is more important than the health and well-being of our Service members, the civilian workforce, and DoD families, and we are committed to taking care of all our people and ensuring that the entire Force remains ready and resilient.”

After the US Supreme Court overturned Roe v Wade in June, Gilbert R. Cisneros Jr., Under Secretary of Defense for Personnel and Readiness, released a memo on “Ensuring Access to Essential Women’s Health Care Services for Service Members, Dependents, Beneficiaries, and Department of Defense Civilian Employees.” In the memo, Cisneros clarified the US Department of Defense (DoD) policies and emphasized, “There will be no interruption to this care.”

Covered abortions—instances where the life of the mother would be endangered if the fetus were carried to term, or when the pregnancy is the result of rape or incest—are still covered. Health care professionals will continue to follow this policy and military medical facilities leadership will implement measures to ensure continued access to care.

The implications of the Supreme Court decision are complicated, Cisneros said. “It is the Department of Justice’s longstanding position that States generally may not impose criminal or civil liability on federal employees who perform their duties in a manner authorized by federal law,” the memo continues. “We will work with the Department of Justice to ensure access to counsel for such civilian employees and Service members if needed and as appropriate.”

The decision also does not affect the DoD’s existing leave policies, which authorize active-duty service members to travel as necessary to receive abortion care. The travel may be government-funded official travel for a covered abortion, or for all other cases, may be undertaken as regular leave at the service member’s expense. DoD civilian employees may continue to use sick leave or other forms of leave to care for themselves or their family members. Sick leave may be used to cover travel to obtain any type of medical treatment.

The Court’s decision “will have significant implications,” Cisneros wrote, adding, “As Secretary Austin has made clear, nothing is more important than the health and well-being of our Service members, the civilian workforce, and DoD families, and we are committed to taking care of all our people and ensuring that the entire Force remains ready and resilient.”

After a 5-year search, the US Senate in a 66-23 vote, confirmed a new US Department of Veterans Affairs (VA) Under Secretary for Health, filling a role that has been without permanent leadership since 2017. Shereef Elnahal, MD, takes over from Steve Lieberman, MD, who has been serving the role in an acting capacity since July 2021.

Elnahal’s nomination had been in limbo since May after Sen. Rick Scott (R-FL) blocked an attempt to fast-track his confirmation, which was led by Sen. John Tester (D-MT) who chairs the Senate Committee on Veterans’ Affairs. Scott, who had no specific objection to Elnahal, argued that President Joseph Biden’s nominees haven’t been qualified. The debate turned acrimonious, with Tester accusing Scott of “turning his back on America’s veterans.” He called Scott’s objection as “obstruction at the worst, because this stops our veterans from getting the health care that they need.”

Tester urged his colleagues to support Elnahal’s confirmation, stressing the importance of filling the position. “Dr. Shereef Elnahal has an impressive record of leading health care systems and agencies and has shown a strong commitment to serving millions of veterans and hardworking employees at VA. Now more than ever,” Tester said, “the Department needs permanent, qualified leadership to guide the nation’s largest integrated health care system in the right direction.”

In a statement, Rep. Mike Bost (R-IL), ranking member of the US House of Representatives Committee on Veterans’ Affairs, agreed, saying, “Dr. Elnahal’s position is a vitally important one, particularly as the VA health care system prepares to care for millions more toxic-exposed veterans under the PACT [Promise to Address Comprehensive Toxics] Act and the new electronic health record rollout continues to disappoint. Dr. Elnahal has his work cut out for him, and I look forward to working with him to ensure that veterans get the health care they have earned when they need it and where they want it, without having to wait too long or travel too far.”

Elnahal is in fact considered well qualified for the job. He was New Jersey’s 21st health commissioner, confirmed unanimously by the New Jersey Senate. During his nearly 2 years in that position, he led with what has become a signature move for him—increasing transparent access to information—by expanding the New Jersey Health Information Network, an interoperability platform that allows for electronic exchange of patient health information among health care providers.

Most recently, as president and CEO of University Hospital in Newark, New Jersey, he oversaw improvements in care quality and patient safety. He also established a partnership to provide supportive housing to patients experiencing homelessness, a hospital-based violence intervention program that has served as a national model, and a program that deploys trusted chaplains as community health workers. Notably, he led the hospital through the COVID-19 crisis; the hospital has served as a model for urban hospital and regional response efforts. Elnahal also set up one of the first COVID-19 vaccination sites in New Jersey.

Moreover, he’s not actually a newcomer to the VA. He served as Assistant Deputy Under Secretary for Health for Quality, Safety, and Value from 2016 through 2018, where he oversaw national policies around quality of care for the Veterans Health Administration (VHA).

During that earlier tenure, he was at the forefront of making VA care more transparent and responsive. Among other things, he cofounded the VHA Innovation Ecosystem, a program that fosters the spread of innovation and best practices. On his watch the VA also launched accesstocare.gov, which provides public access to performance, wait time, and other data. The rationale, Elnahal said in a 2018 interview with Federal Practitioner, was simple: “If we provide veterans with an easy-to-use tool that lets them see data on wait times and quality, they’ll be able to make informed decisions about where and when they receive their health care.” The site allows users to compare quality of care provided by VA medical centers with that of local private hospitals. For instance, they can see if a local VA facility’s wait time is better, worse, or the same as the regional average of private sector clinics.

In his drive to harness smart, sustainable ideas for improving veteran care, Elnahal also helmed the VA Diffusion of Excellence (VADOE) program, whose Shark Tank Competition gives a platform to employees “passionate about solving some of the toughest challenges across VHA.” The innovative winners have included VIONE, a medication deprescribing program, and the β-Lactam Allergy Assessment, an initiative to clarify which patients are truly allergic to BL antibiotics, reduce the incidence of multidrug-resistant infections, and reduce hospital length of stay. Both programs are being replicated across multiple facilities.

“We really empower and recognize the frontline employees who not only contribute the best practices but who replicate them,” Elnahal told Federal Practitioner in 2016. “Essentially, we give them a systemwide leadership role… This is part of many different initiatives that are trying to recognize and elevate the great work that physicians do and really improve their morale and reduce burnout.”

As Rep. Bost suggested, Elnahal now has even more work cut out for him. At this new starting gate, Elnahal says a top priority is improving recruiting and retention for clinical care positions. “The sacred healthcare mission of VA simply cannot be fulfilled without having people to do it, talented healthcare professionals who put the mission above all else.”

In a LinkedIn post, Elnahal thanked President Biden and VA Secretary McDonough for their confidence in him, and the US Senate for confirming him in a bipartisan vote. But “[m]ost of all,” he said, “my gratitude goes to Veterans, families, caregivers, and survivors…. Beyond thrilled and eager to get to work for them in a health system with more than 300,000 heroes. Onward to an incredible journey!”

After a 5-year search, the US Senate in a 66-23 vote, confirmed a new US Department of Veterans Affairs (VA) Under Secretary for Health, filling a role that has been without permanent leadership since 2017. Shereef Elnahal, MD, takes over from Steve Lieberman, MD, who has been serving the role in an acting capacity since July 2021.

Elnahal’s nomination had been in limbo since May after Sen. Rick Scott (R-FL) blocked an attempt to fast-track his confirmation, which was led by Sen. John Tester (D-MT) who chairs the Senate Committee on Veterans’ Affairs. Scott, who had no specific objection to Elnahal, argued that President Joseph Biden’s nominees haven’t been qualified. The debate turned acrimonious, with Tester accusing Scott of “turning his back on America’s veterans.” He called Scott’s objection as “obstruction at the worst, because this stops our veterans from getting the health care that they need.”

Tester urged his colleagues to support Elnahal’s confirmation, stressing the importance of filling the position. “Dr. Shereef Elnahal has an impressive record of leading health care systems and agencies and has shown a strong commitment to serving millions of veterans and hardworking employees at VA. Now more than ever,” Tester said, “the Department needs permanent, qualified leadership to guide the nation’s largest integrated health care system in the right direction.”

In a statement, Rep. Mike Bost (R-IL), ranking member of the US House of Representatives Committee on Veterans’ Affairs, agreed, saying, “Dr. Elnahal’s position is a vitally important one, particularly as the VA health care system prepares to care for millions more toxic-exposed veterans under the PACT [Promise to Address Comprehensive Toxics] Act and the new electronic health record rollout continues to disappoint. Dr. Elnahal has his work cut out for him, and I look forward to working with him to ensure that veterans get the health care they have earned when they need it and where they want it, without having to wait too long or travel too far.”

Elnahal is in fact considered well qualified for the job. He was New Jersey’s 21st health commissioner, confirmed unanimously by the New Jersey Senate. During his nearly 2 years in that position, he led with what has become a signature move for him—increasing transparent access to information—by expanding the New Jersey Health Information Network, an interoperability platform that allows for electronic exchange of patient health information among health care providers.

Most recently, as president and CEO of University Hospital in Newark, New Jersey, he oversaw improvements in care quality and patient safety. He also established a partnership to provide supportive housing to patients experiencing homelessness, a hospital-based violence intervention program that has served as a national model, and a program that deploys trusted chaplains as community health workers. Notably, he led the hospital through the COVID-19 crisis; the hospital has served as a model for urban hospital and regional response efforts. Elnahal also set up one of the first COVID-19 vaccination sites in New Jersey.

Moreover, he’s not actually a newcomer to the VA. He served as Assistant Deputy Under Secretary for Health for Quality, Safety, and Value from 2016 through 2018, where he oversaw national policies around quality of care for the Veterans Health Administration (VHA).

During that earlier tenure, he was at the forefront of making VA care more transparent and responsive. Among other things, he cofounded the VHA Innovation Ecosystem, a program that fosters the spread of innovation and best practices. On his watch the VA also launched accesstocare.gov, which provides public access to performance, wait time, and other data. The rationale, Elnahal said in a 2018 interview with Federal Practitioner, was simple: “If we provide veterans with an easy-to-use tool that lets them see data on wait times and quality, they’ll be able to make informed decisions about where and when they receive their health care.” The site allows users to compare quality of care provided by VA medical centers with that of local private hospitals. For instance, they can see if a local VA facility’s wait time is better, worse, or the same as the regional average of private sector clinics.

In his drive to harness smart, sustainable ideas for improving veteran care, Elnahal also helmed the VA Diffusion of Excellence (VADOE) program, whose Shark Tank Competition gives a platform to employees “passionate about solving some of the toughest challenges across VHA.” The innovative winners have included VIONE, a medication deprescribing program, and the β-Lactam Allergy Assessment, an initiative to clarify which patients are truly allergic to BL antibiotics, reduce the incidence of multidrug-resistant infections, and reduce hospital length of stay. Both programs are being replicated across multiple facilities.

“We really empower and recognize the frontline employees who not only contribute the best practices but who replicate them,” Elnahal told Federal Practitioner in 2016. “Essentially, we give them a systemwide leadership role… This is part of many different initiatives that are trying to recognize and elevate the great work that physicians do and really improve their morale and reduce burnout.”

As Rep. Bost suggested, Elnahal now has even more work cut out for him. At this new starting gate, Elnahal says a top priority is improving recruiting and retention for clinical care positions. “The sacred healthcare mission of VA simply cannot be fulfilled without having people to do it, talented healthcare professionals who put the mission above all else.”

In a LinkedIn post, Elnahal thanked President Biden and VA Secretary McDonough for their confidence in him, and the US Senate for confirming him in a bipartisan vote. But “[m]ost of all,” he said, “my gratitude goes to Veterans, families, caregivers, and survivors…. Beyond thrilled and eager to get to work for them in a health system with more than 300,000 heroes. Onward to an incredible journey!”

After a 5-year search, the US Senate in a 66-23 vote, confirmed a new US Department of Veterans Affairs (VA) Under Secretary for Health, filling a role that has been without permanent leadership since 2017. Shereef Elnahal, MD, takes over from Steve Lieberman, MD, who has been serving the role in an acting capacity since July 2021.

Elnahal’s nomination had been in limbo since May after Sen. Rick Scott (R-FL) blocked an attempt to fast-track his confirmation, which was led by Sen. John Tester (D-MT) who chairs the Senate Committee on Veterans’ Affairs. Scott, who had no specific objection to Elnahal, argued that President Joseph Biden’s nominees haven’t been qualified. The debate turned acrimonious, with Tester accusing Scott of “turning his back on America’s veterans.” He called Scott’s objection as “obstruction at the worst, because this stops our veterans from getting the health care that they need.”

Tester urged his colleagues to support Elnahal’s confirmation, stressing the importance of filling the position. “Dr. Shereef Elnahal has an impressive record of leading health care systems and agencies and has shown a strong commitment to serving millions of veterans and hardworking employees at VA. Now more than ever,” Tester said, “the Department needs permanent, qualified leadership to guide the nation’s largest integrated health care system in the right direction.”

In a statement, Rep. Mike Bost (R-IL), ranking member of the US House of Representatives Committee on Veterans’ Affairs, agreed, saying, “Dr. Elnahal’s position is a vitally important one, particularly as the VA health care system prepares to care for millions more toxic-exposed veterans under the PACT [Promise to Address Comprehensive Toxics] Act and the new electronic health record rollout continues to disappoint. Dr. Elnahal has his work cut out for him, and I look forward to working with him to ensure that veterans get the health care they have earned when they need it and where they want it, without having to wait too long or travel too far.”

Elnahal is in fact considered well qualified for the job. He was New Jersey’s 21st health commissioner, confirmed unanimously by the New Jersey Senate. During his nearly 2 years in that position, he led with what has become a signature move for him—increasing transparent access to information—by expanding the New Jersey Health Information Network, an interoperability platform that allows for electronic exchange of patient health information among health care providers.

Most recently, as president and CEO of University Hospital in Newark, New Jersey, he oversaw improvements in care quality and patient safety. He also established a partnership to provide supportive housing to patients experiencing homelessness, a hospital-based violence intervention program that has served as a national model, and a program that deploys trusted chaplains as community health workers. Notably, he led the hospital through the COVID-19 crisis; the hospital has served as a model for urban hospital and regional response efforts. Elnahal also set up one of the first COVID-19 vaccination sites in New Jersey.

Moreover, he’s not actually a newcomer to the VA. He served as Assistant Deputy Under Secretary for Health for Quality, Safety, and Value from 2016 through 2018, where he oversaw national policies around quality of care for the Veterans Health Administration (VHA).

During that earlier tenure, he was at the forefront of making VA care more transparent and responsive. Among other things, he cofounded the VHA Innovation Ecosystem, a program that fosters the spread of innovation and best practices. On his watch the VA also launched accesstocare.gov, which provides public access to performance, wait time, and other data. The rationale, Elnahal said in a 2018 interview with Federal Practitioner, was simple: “If we provide veterans with an easy-to-use tool that lets them see data on wait times and quality, they’ll be able to make informed decisions about where and when they receive their health care.” The site allows users to compare quality of care provided by VA medical centers with that of local private hospitals. For instance, they can see if a local VA facility’s wait time is better, worse, or the same as the regional average of private sector clinics.

In his drive to harness smart, sustainable ideas for improving veteran care, Elnahal also helmed the VA Diffusion of Excellence (VADOE) program, whose Shark Tank Competition gives a platform to employees “passionate about solving some of the toughest challenges across VHA.” The innovative winners have included VIONE, a medication deprescribing program, and the β-Lactam Allergy Assessment, an initiative to clarify which patients are truly allergic to BL antibiotics, reduce the incidence of multidrug-resistant infections, and reduce hospital length of stay. Both programs are being replicated across multiple facilities.

“We really empower and recognize the frontline employees who not only contribute the best practices but who replicate them,” Elnahal told Federal Practitioner in 2016. “Essentially, we give them a systemwide leadership role… This is part of many different initiatives that are trying to recognize and elevate the great work that physicians do and really improve their morale and reduce burnout.”

As Rep. Bost suggested, Elnahal now has even more work cut out for him. At this new starting gate, Elnahal says a top priority is improving recruiting and retention for clinical care positions. “The sacred healthcare mission of VA simply cannot be fulfilled without having people to do it, talented healthcare professionals who put the mission above all else.”

In a LinkedIn post, Elnahal thanked President Biden and VA Secretary McDonough for their confidence in him, and the US Senate for confirming him in a bipartisan vote. But “[m]ost of all,” he said, “my gratitude goes to Veterans, families, caregivers, and survivors…. Beyond thrilled and eager to get to work for them in a health system with more than 300,000 heroes. Onward to an incredible journey!”

“The Best of DDW” elicits in the minds of most readers a compilation of the most important clinical and scientific content presented at DDW.

But I am not referring to that.

The “Best of DDW 2022” was the American Gastroenterological Association Presidential Plenary Session thanks to the humanity and vision of outgoing AGA President John Inadomi, MD.1 I sat in the audience, misty eyed, as each presenter addressed issues that strike deep into our humanity – the social determinants of health that have festered for far too long, leading to intolerable differences in health outcomes based on accidents of birth, and amplified by racism.

As the table on stage slowly filled in, an amazing picture took shape. A majority of the speakers were Black gastroenterologists and hepatologists, and among them many were young women. As I watched the video of a group of young Black gastroenterologists and hepatologists reaching out to the community, I asked myself “Has anything like this ever happened at a major national medical association meeting in the United States? Ever?” And then it occurred to me: “And just imagine, this exactly 2 days before the 2-year anniversary of the death of George Floyd.”

The plenary session happened on May 23, and I was conscious about the dates because I will never forget that George Floyd was killed on May 25, 2020 – my 55th birthday. The juxtaposition of his death and my birthday 2 years ago shook me profoundly, prompting me to write down my reflections and my hope that, in the national reactions that followed, we were seeing the beginning of true change.2 Two years later, despite our national divisions and serious challenges, I have reasons for hope.

On May 24, I ran into a colleague who was a Black woman. I have stopped being afraid to bring up previously untouchable subjects. I asked her what she thought about the remarkable AGA Plenary. She said she was glad that she is here to see it – that her parents never got the chance.

I admitted to her that I often ask myself what more I could and should be doing. I’m trying to do what I can in recruitment, education, in my personal life. What more? She said that one thing we really need is for people who look like me to amplify the message.

So here it is: Readers, listen to the plenary talks if you were not there. At minimum, behold the following line-up of speakers and topics. Feel the history.

This was the Best of DDW 2022:

• Julius Friedenwald Recognition of Timothy Wang. – John Inadomi.
• Presidential Address: Don’t Talk: Act. The relevance of DEI to gastroenterologists and hepatologists and the imperative for action. – John Inadomi.
• AGA Equity Project: Accomplishments and what lies ahead. – Byron L. Cryer, Sandra M. Quezada.
• The genesis and goals of the Association of Black Gastroenterologists and Hepatologists. – Sophie M. Balzora.
• Increasing racial and ethnic diversity in clinical trials: What we need to do. – Monica Webb Hooper.
• Reducing disparities in colorectal cancer. – Rachel Blankson Issaka.
• Reducing disparities in liver disease. – Lauren Nephew.
• Reducing disparities in IBD. – Fernando Velayos.

Uri Ladabaum, MD, MS, is with the division of gastroenterology and hepatology in the department of medicine at Stanford (Calif.) University. He reports serving on the advisory board for UniversalDx and Lean Medical and as a consultant for Medtronic, Clinical Genomics, Guardant Health, and Freenome. Dr. Ladabaum made these comments during the AGA Institute Presidential Plenary at the annual Digestive Disease Week®.

References

1. Inadomi JM. Gastroenterology. 2022 Jun;162(7):1855-7.

2. Ladabaum U. Ann Intern Med. 2020 Dec 1;173(11):938-9.

“The Best of DDW” elicits in the minds of most readers a compilation of the most important clinical and scientific content presented at DDW.

But I am not referring to that.

The “Best of DDW 2022” was the American Gastroenterological Association Presidential Plenary Session thanks to the humanity and vision of outgoing AGA President John Inadomi, MD.1 I sat in the audience, misty eyed, as each presenter addressed issues that strike deep into our humanity – the social determinants of health that have festered for far too long, leading to intolerable differences in health outcomes based on accidents of birth, and amplified by racism.

As the table on stage slowly filled in, an amazing picture took shape. A majority of the speakers were Black gastroenterologists and hepatologists, and among them many were young women. As I watched the video of a group of young Black gastroenterologists and hepatologists reaching out to the community, I asked myself “Has anything like this ever happened at a major national medical association meeting in the United States? Ever?” And then it occurred to me: “And just imagine, this exactly 2 days before the 2-year anniversary of the death of George Floyd.”

The plenary session happened on May 23, and I was conscious about the dates because I will never forget that George Floyd was killed on May 25, 2020 – my 55th birthday. The juxtaposition of his death and my birthday 2 years ago shook me profoundly, prompting me to write down my reflections and my hope that, in the national reactions that followed, we were seeing the beginning of true change.2 Two years later, despite our national divisions and serious challenges, I have reasons for hope.

On May 24, I ran into a colleague who was a Black woman. I have stopped being afraid to bring up previously untouchable subjects. I asked her what she thought about the remarkable AGA Plenary. She said she was glad that she is here to see it – that her parents never got the chance.

I admitted to her that I often ask myself what more I could and should be doing. I’m trying to do what I can in recruitment, education, in my personal life. What more? She said that one thing we really need is for people who look like me to amplify the message.

So here it is: Readers, listen to the plenary talks if you were not there. At minimum, behold the following line-up of speakers and topics. Feel the history.

This was the Best of DDW 2022:

• Julius Friedenwald Recognition of Timothy Wang. – John Inadomi.
• Presidential Address: Don’t Talk: Act. The relevance of DEI to gastroenterologists and hepatologists and the imperative for action. – John Inadomi.
• AGA Equity Project: Accomplishments and what lies ahead. – Byron L. Cryer, Sandra M. Quezada.
• The genesis and goals of the Association of Black Gastroenterologists and Hepatologists. – Sophie M. Balzora.
• Increasing racial and ethnic diversity in clinical trials: What we need to do. – Monica Webb Hooper.
• Reducing disparities in colorectal cancer. – Rachel Blankson Issaka.
• Reducing disparities in liver disease. – Lauren Nephew.
• Reducing disparities in IBD. – Fernando Velayos.

Uri Ladabaum, MD, MS, is with the division of gastroenterology and hepatology in the department of medicine at Stanford (Calif.) University. He reports serving on the advisory board for UniversalDx and Lean Medical and as a consultant for Medtronic, Clinical Genomics, Guardant Health, and Freenome. Dr. Ladabaum made these comments during the AGA Institute Presidential Plenary at the annual Digestive Disease Week®.

References

1. Inadomi JM. Gastroenterology. 2022 Jun;162(7):1855-7.

2. Ladabaum U. Ann Intern Med. 2020 Dec 1;173(11):938-9.

“The Best of DDW” elicits in the minds of most readers a compilation of the most important clinical and scientific content presented at DDW.

But I am not referring to that.

The “Best of DDW 2022” was the American Gastroenterological Association Presidential Plenary Session thanks to the humanity and vision of outgoing AGA President John Inadomi, MD.1 I sat in the audience, misty eyed, as each presenter addressed issues that strike deep into our humanity – the social determinants of health that have festered for far too long, leading to intolerable differences in health outcomes based on accidents of birth, and amplified by racism.

As the table on stage slowly filled in, an amazing picture took shape. A majority of the speakers were Black gastroenterologists and hepatologists, and among them many were young women. As I watched the video of a group of young Black gastroenterologists and hepatologists reaching out to the community, I asked myself “Has anything like this ever happened at a major national medical association meeting in the United States? Ever?” And then it occurred to me: “And just imagine, this exactly 2 days before the 2-year anniversary of the death of George Floyd.”

The plenary session happened on May 23, and I was conscious about the dates because I will never forget that George Floyd was killed on May 25, 2020 – my 55th birthday. The juxtaposition of his death and my birthday 2 years ago shook me profoundly, prompting me to write down my reflections and my hope that, in the national reactions that followed, we were seeing the beginning of true change.2 Two years later, despite our national divisions and serious challenges, I have reasons for hope.

On May 24, I ran into a colleague who was a Black woman. I have stopped being afraid to bring up previously untouchable subjects. I asked her what she thought about the remarkable AGA Plenary. She said she was glad that she is here to see it – that her parents never got the chance.

I admitted to her that I often ask myself what more I could and should be doing. I’m trying to do what I can in recruitment, education, in my personal life. What more? She said that one thing we really need is for people who look like me to amplify the message.

So here it is: Readers, listen to the plenary talks if you were not there. At minimum, behold the following line-up of speakers and topics. Feel the history.

This was the Best of DDW 2022:

• Julius Friedenwald Recognition of Timothy Wang. – John Inadomi.
• Presidential Address: Don’t Talk: Act. The relevance of DEI to gastroenterologists and hepatologists and the imperative for action. – John Inadomi.
• AGA Equity Project: Accomplishments and what lies ahead. – Byron L. Cryer, Sandra M. Quezada.
• The genesis and goals of the Association of Black Gastroenterologists and Hepatologists. – Sophie M. Balzora.
• Increasing racial and ethnic diversity in clinical trials: What we need to do. – Monica Webb Hooper.
• Reducing disparities in colorectal cancer. – Rachel Blankson Issaka.
• Reducing disparities in liver disease. – Lauren Nephew.
• Reducing disparities in IBD. – Fernando Velayos.

Uri Ladabaum, MD, MS, is with the division of gastroenterology and hepatology in the department of medicine at Stanford (Calif.) University. He reports serving on the advisory board for UniversalDx and Lean Medical and as a consultant for Medtronic, Clinical Genomics, Guardant Health, and Freenome. Dr. Ladabaum made these comments during the AGA Institute Presidential Plenary at the annual Digestive Disease Week®.

References

1. Inadomi JM. Gastroenterology. 2022 Jun;162(7):1855-7.

2. Ladabaum U. Ann Intern Med. 2020 Dec 1;173(11):938-9.

It was a pleasure to serve as editor-in-chief (EIC) of GI & Hepatology News from 2011 to 2016. As the second EIC of the newspaper, I was preceded by Dr. Charles Lightdale – big shoes to fill! I was fortunate to attract a strong group of associate editors who covered many key areas of interest for the paper’s readership. With the enthusiastic support of American Gastroenterological Association staff members, we published once-monthly and received generally positive feedback from readers – predominantly U.S.-based AGA members.

Serving as EIC was also a learning opportunity for me. A number of potentially newsworthy items were brought to my attention – some of which I would not otherwise have seen. Although not all were of direct relevance to the readership, I believe that most of those we published were of value.

One rewarding aspect of the editorship was the opportunity to liaise with those experts from whom I solicited commentaries on some of our featured items. These busy individuals were consistently generous with their time and expertise, and I believe that their contributions added to the paper’s overall appeal.

I initiated the inclusion of two DDSEP questions per edition, and am pleased that this feature continues. One less successful venture was the attempt at a Correspondence section, which ultimately proved too cumbersome to maintain.

I congratulate the AGA on the 15th anniversary of GIHN, and I wish the current EIC, Dr. Megan Adams, and her editorial colleagues continued success in providing this benefit to AGA members.

Colin W. Howden, MD, AGAF, is professor emeritus in the division of gastroenterology, department of medicine, at the University of Tennessee, Memphis. He is a consultant for Allakos, Ironwood, Phathom, and RedHill Biopharma. He is a member of speakers’ bureaus for Alnylam, RedHill Biopharma, and Sanofi/Genzyme. He owns stock in Antibe Therapeutics.

It was a pleasure to serve as editor-in-chief (EIC) of GI & Hepatology News from 2011 to 2016. As the second EIC of the newspaper, I was preceded by Dr. Charles Lightdale – big shoes to fill! I was fortunate to attract a strong group of associate editors who covered many key areas of interest for the paper’s readership. With the enthusiastic support of American Gastroenterological Association staff members, we published once-monthly and received generally positive feedback from readers – predominantly U.S.-based AGA members.

Serving as EIC was also a learning opportunity for me. A number of potentially newsworthy items were brought to my attention – some of which I would not otherwise have seen. Although not all were of direct relevance to the readership, I believe that most of those we published were of value.

One rewarding aspect of the editorship was the opportunity to liaise with those experts from whom I solicited commentaries on some of our featured items. These busy individuals were consistently generous with their time and expertise, and I believe that their contributions added to the paper’s overall appeal.

I initiated the inclusion of two DDSEP questions per edition, and am pleased that this feature continues. One less successful venture was the attempt at a Correspondence section, which ultimately proved too cumbersome to maintain.

I congratulate the AGA on the 15th anniversary of GIHN, and I wish the current EIC, Dr. Megan Adams, and her editorial colleagues continued success in providing this benefit to AGA members.

Colin W. Howden, MD, AGAF, is professor emeritus in the division of gastroenterology, department of medicine, at the University of Tennessee, Memphis. He is a consultant for Allakos, Ironwood, Phathom, and RedHill Biopharma. He is a member of speakers’ bureaus for Alnylam, RedHill Biopharma, and Sanofi/Genzyme. He owns stock in Antibe Therapeutics.

It was a pleasure to serve as editor-in-chief (EIC) of GI & Hepatology News from 2011 to 2016. As the second EIC of the newspaper, I was preceded by Dr. Charles Lightdale – big shoes to fill! I was fortunate to attract a strong group of associate editors who covered many key areas of interest for the paper’s readership. With the enthusiastic support of American Gastroenterological Association staff members, we published once-monthly and received generally positive feedback from readers – predominantly U.S.-based AGA members.

Serving as EIC was also a learning opportunity for me. A number of potentially newsworthy items were brought to my attention – some of which I would not otherwise have seen. Although not all were of direct relevance to the readership, I believe that most of those we published were of value.

One rewarding aspect of the editorship was the opportunity to liaise with those experts from whom I solicited commentaries on some of our featured items. These busy individuals were consistently generous with their time and expertise, and I believe that their contributions added to the paper’s overall appeal.

I initiated the inclusion of two DDSEP questions per edition, and am pleased that this feature continues. One less successful venture was the attempt at a Correspondence section, which ultimately proved too cumbersome to maintain.

I congratulate the AGA on the 15th anniversary of GIHN, and I wish the current EIC, Dr. Megan Adams, and her editorial colleagues continued success in providing this benefit to AGA members.

Colin W. Howden, MD, AGAF, is professor emeritus in the division of gastroenterology, department of medicine, at the University of Tennessee, Memphis. He is a consultant for Allakos, Ironwood, Phathom, and RedHill Biopharma. He is a member of speakers’ bureaus for Alnylam, RedHill Biopharma, and Sanofi/Genzyme. He owns stock in Antibe Therapeutics.

Dear colleagues,

It is with bittersweet sentiments that I introduce my last issue of The New Gastroenterologist as its Editor-in-Chief. As I reflect on my time as EIC, I am immensely grateful to the AGA for this opportunity and am proud of the journal’s continuing evolution.

To begin with this issue’s content, our “In Focus” clinical feature reviews nonalcoholic fatty liver disease (NAFLD) and is written by Dr. Naga Chalasani and Dr. Eduardo Vilar-Gomez (Indiana University). This is an excellent, comprehensive piece that details the diagnosis of NAFLD and a multifaceted management approach including dietary and lifestyle modifications, pharmacotherapy, and surgical options.

Learning endoscopy is hard, but so is teaching it. Dr. Navin Kumar (Brigham and Women’s Hospital) lends tangible advice to faculty on how to optimize their endoscopy teaching skills.

Our short clinical review for this quarter, brought to you by Dr. Grace Kim and Dr. Uzma Siddiqui (University of Chicago), offers a helpful discussion on appropriate endoscopic management of duodenal and ampullary adenomas.

Statistical concepts can often be difficult to understand; Dr. Manol Jovani (University of Kentucky) provides a useful, practical explanation of effect modification.

The AGA editorial fellowship is a wonderful opportunity and we are fortunate to have two current fellows share their experience in this issue. Dr. Judy Trieu (Loyola University Chicago) discusses her experience with Clinical Gastroenterology and Hepatology and Dr. Helenie Kefalakes (Hannover Medical School – Germany) reports on her time with Gastroenterology.

Ethics manifests itself in gastroenterology in many ways, and I am happy to have introduced a case-based ethics series to our publication. For my last issue, Dr. Ariel Sims (University of Chicago) and I discuss a case of repeated deliberate foreign body ingestion and the ethical considerations for us as endoscopists.

It can be difficult to navigate the many options that exist within the realm of disability insurance. Dr. Trevor Smith (Advanced EyeCare Professionals) reviews the reasons to obtain disability insurance, how to apply and what to look for in a policy.

Lastly, the DHPA Private Practice Perspectives article for this issue is written by Dr. Marc Sonenshine (Atlanta Gastroenterology Associates) who shares his practice’s innovative approach to implementing a formalized mentorship program for physicians early in their career.

As my editorship comes to a close, I would be remiss not to thank several key people who have been instrumental in the last 3 years. First, Dr. Gautham Reddy, an important mentor of mine and former program director who sent me this opportunity and encouraged me to apply. In addition, I am grateful to the chief of our Section at the University of Chicago, Dr. David Rubin, for his collaboration and support. Ryan Farrell, the managing editor of TNG, has been nothing short of amazing to work with and is the true backbone of our publication. I would also like to thank the staff of our publisher, Frontline Medical Communications, especially Kathy Scarbeck and Christopher Palmer, as well as the EIC and former EIC of our parent publication, GI & Hepatology News, Dr. Megan Adams and Dr. John Allen. Finally, thank you to our readers, whose continued interest has made TNG a success.

Taken together, my experience as EIC of TNG for the last 3 years has been unparalleled. The opportunity to translate the questions, challenges, and experiences of early-career gastroenterologists into written pieces that would be shared with the international community is one I truly never thought I would find within a career in medicine. I am excited for the future and growth of TNG in the hands of a new EIC.

If you have interest in contributing or have ideas for future TNG topics, please contact me ([email protected]) or Ryan Farrell ([email protected]), managing editor of TNG.

Respectfully,

Vijaya L. Rao, MD
Editor-in-Chief

Dear colleagues,

It is with bittersweet sentiments that I introduce my last issue of The New Gastroenterologist as its Editor-in-Chief. As I reflect on my time as EIC, I am immensely grateful to the AGA for this opportunity and am proud of the journal’s continuing evolution.

To begin with this issue’s content, our “In Focus” clinical feature reviews nonalcoholic fatty liver disease (NAFLD) and is written by Dr. Naga Chalasani and Dr. Eduardo Vilar-Gomez (Indiana University). This is an excellent, comprehensive piece that details the diagnosis of NAFLD and a multifaceted management approach including dietary and lifestyle modifications, pharmacotherapy, and surgical options.

Learning endoscopy is hard, but so is teaching it. Dr. Navin Kumar (Brigham and Women’s Hospital) lends tangible advice to faculty on how to optimize their endoscopy teaching skills.

Our short clinical review for this quarter, brought to you by Dr. Grace Kim and Dr. Uzma Siddiqui (University of Chicago), offers a helpful discussion on appropriate endoscopic management of duodenal and ampullary adenomas.

Statistical concepts can often be difficult to understand; Dr. Manol Jovani (University of Kentucky) provides a useful, practical explanation of effect modification.

The AGA editorial fellowship is a wonderful opportunity and we are fortunate to have two current fellows share their experience in this issue. Dr. Judy Trieu (Loyola University Chicago) discusses her experience with Clinical Gastroenterology and Hepatology and Dr. Helenie Kefalakes (Hannover Medical School – Germany) reports on her time with Gastroenterology.

Ethics manifests itself in gastroenterology in many ways, and I am happy to have introduced a case-based ethics series to our publication. For my last issue, Dr. Ariel Sims (University of Chicago) and I discuss a case of repeated deliberate foreign body ingestion and the ethical considerations for us as endoscopists.

It can be difficult to navigate the many options that exist within the realm of disability insurance. Dr. Trevor Smith (Advanced EyeCare Professionals) reviews the reasons to obtain disability insurance, how to apply and what to look for in a policy.

Lastly, the DHPA Private Practice Perspectives article for this issue is written by Dr. Marc Sonenshine (Atlanta Gastroenterology Associates) who shares his practice’s innovative approach to implementing a formalized mentorship program for physicians early in their career.

As my editorship comes to a close, I would be remiss not to thank several key people who have been instrumental in the last 3 years. First, Dr. Gautham Reddy, an important mentor of mine and former program director who sent me this opportunity and encouraged me to apply. In addition, I am grateful to the chief of our Section at the University of Chicago, Dr. David Rubin, for his collaboration and support. Ryan Farrell, the managing editor of TNG, has been nothing short of amazing to work with and is the true backbone of our publication. I would also like to thank the staff of our publisher, Frontline Medical Communications, especially Kathy Scarbeck and Christopher Palmer, as well as the EIC and former EIC of our parent publication, GI & Hepatology News, Dr. Megan Adams and Dr. John Allen. Finally, thank you to our readers, whose continued interest has made TNG a success.

Taken together, my experience as EIC of TNG for the last 3 years has been unparalleled. The opportunity to translate the questions, challenges, and experiences of early-career gastroenterologists into written pieces that would be shared with the international community is one I truly never thought I would find within a career in medicine. I am excited for the future and growth of TNG in the hands of a new EIC.

If you have interest in contributing or have ideas for future TNG topics, please contact me ([email protected]) or Ryan Farrell ([email protected]), managing editor of TNG.

Respectfully,

Vijaya L. Rao, MD
Editor-in-Chief

Dear colleagues,

It is with bittersweet sentiments that I introduce my last issue of The New Gastroenterologist as its Editor-in-Chief. As I reflect on my time as EIC, I am immensely grateful to the AGA for this opportunity and am proud of the journal’s continuing evolution.

To begin with this issue’s content, our “In Focus” clinical feature reviews nonalcoholic fatty liver disease (NAFLD) and is written by Dr. Naga Chalasani and Dr. Eduardo Vilar-Gomez (Indiana University). This is an excellent, comprehensive piece that details the diagnosis of NAFLD and a multifaceted management approach including dietary and lifestyle modifications, pharmacotherapy, and surgical options.

Learning endoscopy is hard, but so is teaching it. Dr. Navin Kumar (Brigham and Women’s Hospital) lends tangible advice to faculty on how to optimize their endoscopy teaching skills.

Our short clinical review for this quarter, brought to you by Dr. Grace Kim and Dr. Uzma Siddiqui (University of Chicago), offers a helpful discussion on appropriate endoscopic management of duodenal and ampullary adenomas.

Statistical concepts can often be difficult to understand; Dr. Manol Jovani (University of Kentucky) provides a useful, practical explanation of effect modification.

The AGA editorial fellowship is a wonderful opportunity and we are fortunate to have two current fellows share their experience in this issue. Dr. Judy Trieu (Loyola University Chicago) discusses her experience with Clinical Gastroenterology and Hepatology and Dr. Helenie Kefalakes (Hannover Medical School – Germany) reports on her time with Gastroenterology.

Ethics manifests itself in gastroenterology in many ways, and I am happy to have introduced a case-based ethics series to our publication. For my last issue, Dr. Ariel Sims (University of Chicago) and I discuss a case of repeated deliberate foreign body ingestion and the ethical considerations for us as endoscopists.

It can be difficult to navigate the many options that exist within the realm of disability insurance. Dr. Trevor Smith (Advanced EyeCare Professionals) reviews the reasons to obtain disability insurance, how to apply and what to look for in a policy.

Lastly, the DHPA Private Practice Perspectives article for this issue is written by Dr. Marc Sonenshine (Atlanta Gastroenterology Associates) who shares his practice’s innovative approach to implementing a formalized mentorship program for physicians early in their career.

As my editorship comes to a close, I would be remiss not to thank several key people who have been instrumental in the last 3 years. First, Dr. Gautham Reddy, an important mentor of mine and former program director who sent me this opportunity and encouraged me to apply. In addition, I am grateful to the chief of our Section at the University of Chicago, Dr. David Rubin, for his collaboration and support. Ryan Farrell, the managing editor of TNG, has been nothing short of amazing to work with and is the true backbone of our publication. I would also like to thank the staff of our publisher, Frontline Medical Communications, especially Kathy Scarbeck and Christopher Palmer, as well as the EIC and former EIC of our parent publication, GI & Hepatology News, Dr. Megan Adams and Dr. John Allen. Finally, thank you to our readers, whose continued interest has made TNG a success.

Taken together, my experience as EIC of TNG for the last 3 years has been unparalleled. The opportunity to translate the questions, challenges, and experiences of early-career gastroenterologists into written pieces that would be shared with the international community is one I truly never thought I would find within a career in medicine. I am excited for the future and growth of TNG in the hands of a new EIC.

If you have interest in contributing or have ideas for future TNG topics, please contact me ([email protected]) or Ryan Farrell ([email protected]), managing editor of TNG.

Respectfully,

Vijaya L. Rao, MD
Editor-in-Chief

Join us at AGA Advocacy Day on Thursday, Sept. 22, 2022, to virtually meet with your members of Congress to urge them to rein in insurance policies like prior authorization and step therapy.

If GI providers don’t have a seat at the table and engage with lawmakers, these decisions will be influenced by payers and other parties that do not have your or your patients’ best interests at heart.

AGA Advocacy Day is held shortly before the end of the fiscal year – prime time to educate policymakers and their staff about your everyday challenges and the reality of GI patient care in your state. We will also discuss the need for robust federal funding for GI research and the devastating impact that Medicare cuts could have on your practice.

Register today and AGA will take care of the rest, including scheduling your meetings and providing comprehensive advocacy training. Now more than ever, your voice needs to be heard on Capitol Hill.

Join us at AGA Advocacy Day on Thursday, Sept. 22, 2022, to virtually meet with your members of Congress to urge them to rein in insurance policies like prior authorization and step therapy.

If GI providers don’t have a seat at the table and engage with lawmakers, these decisions will be influenced by payers and other parties that do not have your or your patients’ best interests at heart.

AGA Advocacy Day is held shortly before the end of the fiscal year – prime time to educate policymakers and their staff about your everyday challenges and the reality of GI patient care in your state. We will also discuss the need for robust federal funding for GI research and the devastating impact that Medicare cuts could have on your practice.

Register today and AGA will take care of the rest, including scheduling your meetings and providing comprehensive advocacy training. Now more than ever, your voice needs to be heard on Capitol Hill.

Join us at AGA Advocacy Day on Thursday, Sept. 22, 2022, to virtually meet with your members of Congress to urge them to rein in insurance policies like prior authorization and step therapy.

If GI providers don’t have a seat at the table and engage with lawmakers, these decisions will be influenced by payers and other parties that do not have your or your patients’ best interests at heart.

AGA Advocacy Day is held shortly before the end of the fiscal year – prime time to educate policymakers and their staff about your everyday challenges and the reality of GI patient care in your state. We will also discuss the need for robust federal funding for GI research and the devastating impact that Medicare cuts could have on your practice.

Register today and AGA will take care of the rest, including scheduling your meetings and providing comprehensive advocacy training. Now more than ever, your voice needs to be heard on Capitol Hill.

The American Gastroenterological Association Research Foundation is the charitable arm of the AGA and plays an important role in medical research by providing grants to young scientists at a critical time in their career.

“I am beyond excited to be able to continue my journey as a young physician-scientist with the funding support. I truly understand that my career would not be possible without those who generously support scientific research. I am humbled at the opportunity to contribute to something larger than myself. As such, I am extremely grateful to the AGA Research Foundation and its donors who continue to support this vision of a future where suffering related to digestive diseases has been eliminated,” said Brian A. Sullivan, MD, a 2021 AGA Research Scholar Award recipient, who is a physician-scientist who aspires to lead a collaborative research program and develop more effective strategies for colorectal cancer prevention.

In the past decade alone, we’ve witnessed seminal work in colorectal cancer genetics and a renaissance in the understanding of inflammatory bowel syndrome and the gut microbiome. However, continued progress in advancing the treatment and cure of digestive diseases is at risk because of cuts in government spending. Without help from other funding sources, young investigators are struggling to continue their research, build their research portfolio, and obtain federal funding.
 

Your contribution makes a difference 

With donations from AGA members, we can provide young researchers with a secure, ongoing stable source of funding that drives advancement in the diagnosis, treatment and cure of digestive diseases. Everyone benefits from GI research developed by dedicated investigators.

“I donated to the AGA Research Foundation to ensure the vitality of our specialty, and to fund the research of future generations of gastroenterologists. Funding from organizations like the AGA Research Foundation is crucial for young scientists and gastroenterologists to launch their careers. At the start of my career, I received two AGA research awards. As a grateful recipient of such funding, I felt it was my turn to support the mission of the organization that I regard as my academic home away from home institution,” said Michael Camilleri, MD, AGAF, chair of the AGA Research Foundation and AGA Past President.

Many breakthroughs have been achieved through gastroenterological and hepatological research over the past century, forming the basis of the modern medical practice. Join fellow AGA members by contributing to this tradition of discovery. 

Make a tax-deductible donation to the AGA Research Foundation at www.gastro.org/donate or by mail to 4930 Del Ray Avenue, Bethesda, MD 20814.

Learn more about the AGA Research Foundation at https://foundation.gastro.org. 

The American Gastroenterological Association Research Foundation is the charitable arm of the AGA and plays an important role in medical research by providing grants to young scientists at a critical time in their career.

“I am beyond excited to be able to continue my journey as a young physician-scientist with the funding support. I truly understand that my career would not be possible without those who generously support scientific research. I am humbled at the opportunity to contribute to something larger than myself. As such, I am extremely grateful to the AGA Research Foundation and its donors who continue to support this vision of a future where suffering related to digestive diseases has been eliminated,” said Brian A. Sullivan, MD, a 2021 AGA Research Scholar Award recipient, who is a physician-scientist who aspires to lead a collaborative research program and develop more effective strategies for colorectal cancer prevention.

In the past decade alone, we’ve witnessed seminal work in colorectal cancer genetics and a renaissance in the understanding of inflammatory bowel syndrome and the gut microbiome. However, continued progress in advancing the treatment and cure of digestive diseases is at risk because of cuts in government spending. Without help from other funding sources, young investigators are struggling to continue their research, build their research portfolio, and obtain federal funding.
 

Your contribution makes a difference 

With donations from AGA members, we can provide young researchers with a secure, ongoing stable source of funding that drives advancement in the diagnosis, treatment and cure of digestive diseases. Everyone benefits from GI research developed by dedicated investigators.

“I donated to the AGA Research Foundation to ensure the vitality of our specialty, and to fund the research of future generations of gastroenterologists. Funding from organizations like the AGA Research Foundation is crucial for young scientists and gastroenterologists to launch their careers. At the start of my career, I received two AGA research awards. As a grateful recipient of such funding, I felt it was my turn to support the mission of the organization that I regard as my academic home away from home institution,” said Michael Camilleri, MD, AGAF, chair of the AGA Research Foundation and AGA Past President.

Many breakthroughs have been achieved through gastroenterological and hepatological research over the past century, forming the basis of the modern medical practice. Join fellow AGA members by contributing to this tradition of discovery. 

Make a tax-deductible donation to the AGA Research Foundation at www.gastro.org/donate or by mail to 4930 Del Ray Avenue, Bethesda, MD 20814.

Learn more about the AGA Research Foundation at https://foundation.gastro.org. 

The American Gastroenterological Association Research Foundation is the charitable arm of the AGA and plays an important role in medical research by providing grants to young scientists at a critical time in their career.

“I am beyond excited to be able to continue my journey as a young physician-scientist with the funding support. I truly understand that my career would not be possible without those who generously support scientific research. I am humbled at the opportunity to contribute to something larger than myself. As such, I am extremely grateful to the AGA Research Foundation and its donors who continue to support this vision of a future where suffering related to digestive diseases has been eliminated,” said Brian A. Sullivan, MD, a 2021 AGA Research Scholar Award recipient, who is a physician-scientist who aspires to lead a collaborative research program and develop more effective strategies for colorectal cancer prevention.

In the past decade alone, we’ve witnessed seminal work in colorectal cancer genetics and a renaissance in the understanding of inflammatory bowel syndrome and the gut microbiome. However, continued progress in advancing the treatment and cure of digestive diseases is at risk because of cuts in government spending. Without help from other funding sources, young investigators are struggling to continue their research, build their research portfolio, and obtain federal funding.
 

Your contribution makes a difference 

With donations from AGA members, we can provide young researchers with a secure, ongoing stable source of funding that drives advancement in the diagnosis, treatment and cure of digestive diseases. Everyone benefits from GI research developed by dedicated investigators.

“I donated to the AGA Research Foundation to ensure the vitality of our specialty, and to fund the research of future generations of gastroenterologists. Funding from organizations like the AGA Research Foundation is crucial for young scientists and gastroenterologists to launch their careers. At the start of my career, I received two AGA research awards. As a grateful recipient of such funding, I felt it was my turn to support the mission of the organization that I regard as my academic home away from home institution,” said Michael Camilleri, MD, AGAF, chair of the AGA Research Foundation and AGA Past President.

Many breakthroughs have been achieved through gastroenterological and hepatological research over the past century, forming the basis of the modern medical practice. Join fellow AGA members by contributing to this tradition of discovery. 

Make a tax-deductible donation to the AGA Research Foundation at www.gastro.org/donate or by mail to 4930 Del Ray Avenue, Bethesda, MD 20814.

Learn more about the AGA Research Foundation at https://foundation.gastro.org.